Tranexamic acid in patients with traumatic brain injury: a meta-analysis.

BACKGROUND: We performed a meta-analysis to assess the effectiveness and safety of tranexamic acid in patients with traumatic brain injury (TBI). METHODS: We searched the literature for articles evaluating the effectiveness and safety of tranexamic acid (TXA) in TBI published between January 2012 and January 2021, and identified 8 studies with a total of 10860 patients: 5660 received TXA and 5200 served as controls. We used a dichotomous or continuous approach with a random or fixed-effect model to assess the efficacy and safety of TXA in TBI, and calculated the mean difference (MD) and odds ratio (OR) with the corresponding 95% confidence interval. RESULTS: In patients with TBI, early administration of TXA was associated with a greater relative benefit (MD -2.45; 95% CI = -4.78 to -0.12; p=0.04) and less total haematoma expansion (MD - 2.52; 95% CI = -4.85 to -0.19; p=0.03) compared to controls. There were no statistically significant differences in mortality (OR 0.94; 95% CI=0.85-1.03; p=0.18), presence of progressive haemorrhage (OR 0.75; 95% CI=0.56-1.01; p=0.06), need for neurosurgery (OR 1.15; 95% CI=0.66-1.98; p=0.63), high Disability Rating Scale score (OR 0.90; 95% CI=0.56-1.45; p=0.68), and incidence of ischaemic or thromboembolic complications (OR 1.34; 95% CI=0.33-5.46; p=0.68) between TBI patients treated with TXA and controls. CONCLUSIONS: Early administration of TXA in TBI patients may have a greater relative benefit and may inhibit haematoma expansion. There were no significant differences in mortality, presence of progressive haemorrhage, need for neurosurgery, high Disability Rating Scale score, and incidence of ischaemic or thromboembolic complications between TBI patients treated with TXA and controls. Further studies are needed to validate these results.

Uso preoperatorio de fármacos hemostáticos para disminuir la transfusión de hemocomponentes en histerectomía total abdominal / Preoperative use of hemostatic drugs to reduce hemocomponent transfusion in total abdominal hysterectomy

Resumen: Introducción: en la actualidad se usan fármacos para disminuir el sangrado transoperatorio, la transfusión de hemoderivados como el ácido tranexámico que es un antifibrinolítico análogo de la lisina y desmopresina que actúa incrementando de forma autóloga el factor VIII y el factor de Von Willebrand (FVW) en individuos sanos. Objetivo: demostrar la eficacia del uso y seguridad del ácido tranexámico vs desmopresina para disminuir la transfusión de hemocomponentes en pacientes sometidos a histerectomía total abdominal electiva. Material y métodos: se estudiaron 72 pacientes, los cuales se dividieron en dos grupos (36 pacientes cada uno) asignados al azar para recibir ácido tranexámico 10 mg/kg de peso o desmopresina 0.3 mg/kg de peso, ambos por vía intravenosa 20 minutos previo al evento quirúrgico. Resultados: en comparación del ácido tranexámico contra desmopresina para la disminución del sangrado transoperatorio, 100% de las pacientes a las que se les administró el ácido tranexámico no requirieron transfusión de hemoderivados y presentado el 100% de efectividad siendo estadísticamente significativos con un valor de p < 0.05. Conclusiones: la administración de ácido tranexámico resultó más eficaz para disminuir la administración de hemoderivados en pacientes sometidos a histerectomía total abdominal electiva. Además, no se presentaron efectos adversos graves durante su administración.

Abstract: Introduction: drugs are currently used to reduce intraoperative bleeding, transfusion of blood products such as tranexamic acid, which is an antifibinolytic lysine analogue, and desmopressin, which acts by autologously increasing factor VIII and VWF in healthy individuals. Objective: demonstrate the efficacy of the use and safety of tranexamic acid vs desmopressin to reduce the transfusion of blood components in patients undergoing elective total abdominal hysterectomy. Material and methods: 72 patients were studied, divided into two groups (36 patients each one) randomly assigned to receive tranexamic acid 10 mg/kg weight or desmopressin 0.3 mg/kg weight, both intravenously 20 minutes prior to the surgical event. Results: the comparison of tranexamic acid against desmopressin for the reduction of intraoperative bleeding, 100% of the patients who were administered tranexamic acid did not require transfusion of blood products and presented 100% effectiveness, being statistically significant with a value of p < 0.05. Conclusions: the administration of tranexamic acid was more effective in reducing the administration of blood products in patients undergoing elective total abdominal hysterectomy.

Eficacia del ácido tranexámico tópico en la artroplastia invertida de hombro / The efficacy of topical tranexamic acid in reverse shoulder arthroplasty

Introducción: El ácido tranexámico (ATX) tópico ha demostrado disminuir de forma significativa el sangrado en artroplastia de cadera y rodilla. A pesar de que en la artroplastia de hombro la mayoría de trabajos han demostrado su eficacia por vía intravenosa, la eficacia y dosis por vía tópica aún no está determinada. El objetivo fue comprobar si 1,5g de ATX en bajo volumen (30mL) administrado de manera tópica disminuiría el sangrado tras la artroplastia invertida de hombro (AIH). Material y métodos: Se revisaron de manera retrospectiva 177 pacientes consecutivos intervenidos de AIH por artropatía y fractura. Se recogieron datos de ΔHb y ΔHto a las 24h, débito del drenaje (mL), estancia media y complicaciones. Resultados: Los pacientes que recibieron ATX presentaron menor débito del drenaje tanto en artroplastia electiva (AIHE) (104 vs. 195mL, p=0,004) como por fractura (AIHF) (47 vs. 79mL, p=0,01). Aunque fue ligeramente menor en el grupo de ATX, no se observaron diferencias estadísticamente significativas en el sangrado sistémico (AIHE ΔHb 1,67 vs. 1,90mg/dL, AIHF 2,61 vs. 2,7mg/dL, p=0,79), estancia media (AIHE 2,0 vs. 2,3 días, p=0,34; 2,3 vs. 2,5, p=0,56) o necesidad de transfusión (0% en AIHE; AIHF 5% vs. 7%, p=0,66). Los pacientes intervenidos por fractura presentaron mayor tasa de complicaciones que aquellos que lo hicieron por artropatía (7% vs. 15,6%, p=0,04). No se observaron complicaciones asociadas al uso de ATX. Conclusión: La administración tópica de 1,5g de ATX reduce el sangrado de manera significativa en el sitio quirúrgico sin observarse complicaciones asociadas. La disminución del hematoma posquirúrgico permitiría evitar el uso sistemático de drenajes posquirúrgicos.(AU)

Introduction: Topical tranexamic acid (TXA) has been shown to decrease blood loss in knee and hip arthroplasty. Despite there is evidence about its effectiveness when administered intravenous, its effectiveness and optimal dose when used topically has not been established. We hypothesized that the use of 1.5g (30mL) of topical TXA could decrease the amount of blood loss in patients after reverse total shoulder arthroplasty (RTSA). Material and methods: One hundred and seventy-seven patients receiving a RSTA for arthropathy or fracture were retrospectively reviewed. Preoperative-to-postoperative change in hemoglobin (ΔHb) and hematocrit (ΔHct) level drain volume output, length of stay and complications were evaluated for each patient. Results: Patients receiving TXA has significant less drain output in both for arthropathy (ARSA) (104 vs. 195mL, p=0.004) and fracture (FRSA) (47 vs. 79mL, p=0.01). Systemic blood loss was slightly lower in TXA group, but this was not statistically significant (ARSA, ΔHb 1.67 vs. 1.90mg/dL, FRSA 2.61 vs. 2.7mg/dL, p=0.79). This was also observed in hospital length of stay (ARSA 2.0 vs. 2.3 days, p=0.34; 2.3 vs. 2.5, p=0.56) and need of transfusion (0% AIHE; AIHF 5% vs. 7%, p=0.66). Patients operated for a fracture had a higher rate of complications (7% vs. 15.6%, p=0.04). There were no adverse events related to TXA administration. Conclusion: Topical use of 1.5g of TXA decreases blood loss, especially on the surgical site without associated complications. Thus, hematoma decrease could avoid the systematic use of postoperative drains after reverse shoulder arthroplasty.(AU)

[Translated article] The efficacy of topical tranexamic acid in reverse shoulder arthroplasty / Eficacia del ácido tranexámico tópico en la artroplastia invertida de hombro

Introducción: El ácido tranexámico (ATX) tópico ha demostrado disminuir de forma significativa el sangrado en artroplastia de cadera y rodilla. A pesar de que en la artroplastia de hombro la mayoría de trabajos han demostrado su eficacia por vía intravenosa, la eficacia y dosis por vía tópica aún no está determinada. El objetivo fue comprobar si 1,5g de ATX en bajo volumen (30mL) administrado de manera tópica disminuiría el sangrado tras la artroplastia invertida de hombro (AIH). Material y métodos: Se revisaron de manera retrospectiva 177 pacientes consecutivos intervenidos de AIH por artropatía y fractura. Se recogieron datos de ΔHb y ΔHto a las 24h, débito del drenaje (mL), estancia media y complicaciones. Resultados: Los pacientes que recibieron ATX presentaron menor débito del drenaje tanto en artroplastia electiva (AIHE) (104 vs. 195mL, p=0,004) como por fractura (AIHF) (47 vs. 79mL, p=0,01). Aunque fue ligeramente menor en el grupo de ATX, no se observaron diferencias estadísticamente significativas en el sangrado sistémico (AIHE ΔHb 1,67 vs. 1,90mg/dL, AIHF 2,61 vs. 2,7mg/dL, p=0,79), estancia media (AIHE 2,0 vs. 2,3 días, p=0,34; 2,3 vs. 2,5, p=0,56) o necesidad de transfusión (0% en AIHE; AIHF 5% vs. 7%, p=0,66). Los pacientes intervenidos por fractura presentaron mayor tasa de complicaciones que aquellos que lo hicieron por artropatía (7% vs. 15,6%, p=0,04). No se observaron complicaciones asociadas al uso de ATX. Conclusión: La administración tópica de 1,5g de ATX reduce el sangrado de manera significativa en el sitio quirúrgico sin observarse complicaciones asociadas. La disminución del hematoma posquirúrgico permitiría evitar el uso sistemático de drenajes posquirúrgicos.(AU)

Introduction: Topical tranexamic acid (TXA) has been shown to decrease blood loss in knee and hip arthroplasty. Despite there is evidence about its effectiveness when administered intravenous, its effectiveness and optimal dose when used topically has not been established. We hypothesized that the use of 1.5g (30mL) of topical TXA could decrease the amount of blood loss in patients after reverse total shoulder arthroplasty (RTSA). Material and methods: One hundred and seventy-seven patients receiving a RSTA for arthropathy or fracture were retrospectively reviewed. Preoperative-to-postoperative change in hemoglobin (ΔHb) and hematocrit (ΔHct) level drain volume output, length of stay and complications were evaluated for each patient. Results: Patients receiving TXA has significant less drain output in both for arthropathy (ARSA) (104 vs. 195mL, p=0.004) and fracture (FRSA) (47 vs. 79mL, p=0.01). Systemic blood loss was slightly lower in TXA group, but this was not statistically significant (ARSA, ΔHb 1.67 vs. 1.90mg/dL, FRSA 2.61 vs. 2.7mg/dL, p=0.79). This was also observed in hospital length of stay (ARSA 2.0 vs. 2.3 days, p=0.34; 2.3 vs. 2.5, p=0.56) and need of transfusion (0% AIHE; AIHF 5% vs. 7%, p=0.66). Patients operated for a fracture had a higher rate of complications (7% vs. 15.6%, p=0.04). There were no adverse events related to TXA administration. Conclusion: Topical use of 1.5g of TXA decreases blood loss, especially on the surgical site without associated complications. Thus, hematoma decrease could avoid the systematic use of postoperative drains after reverse shoulder arthroplasty.(AU)

Accidente fatal debido al uso de ácido tranexámico vía intratecal. Presentación de caso

Los errores en la administración de medicamentos durante la anestesia continúan siendo una causa importante de morbimortalidad, incluso en países industrializados. El ácido tranexámico es un agente antifibrinolítico indicado para reducir el sangramiento perioperatorio en varios procederes quirúrgicos. Se presenta el caso de una gestante de 23 años con 37,2 semanas de gestación, en el Baringo Country Referral Hospital, de Kenia. Durante la administración de la anestesia raquídea en la cesárea, se le aplicó de forma accidental este medicamento por vía intratecal. La paciente comenzó con mioclonías de miembros inferiores, convulsiones tonicoclónicas, y llegó a la parada cardiorrespiratoria. Se ingresó en Cuidados Intensivos, donde se identificaron signos indirectos de muerte encefálica, y falleció al sexto día de su ingreso. La literatura reporta que la mortalidad por este accidente anestésico en embarazadas es muy elevada, debido a altas concentraciones del medicamento en el líquido cefalorraquídeo.

Errors in the drugs administration during anesthesia continue to be a major cause of morbidity and mortality, even in industrialized countries. Tranexamic acid is an antifibrinolytic agent indicated to reduce perioperative bleeding in several surgical procedures. The case of a 23-years-old pregnant woman with 32.7 weeks of pregnancy treated at the Baringo Referral Hospital, in Kenya, is presented. During the administration of spinal anesthesia in the cesarean section, this medication was accidentally applied intrathecally. The patient began with myoclonus of the lower limbs, tonic-clonic seizures, and reached cardio-respiratory arrest. She was admitted to Intensive Care, where indirect signs of brain death were identified, and she died on the six day after admission. The literature reports that mortality for this anesthetic accident is very high, due to high concentration of the drug in the cerebrospinal fluid.

Intravenous Use of Tranexamic Acid in Total Knee Arthroplasty with no Tourniquet / O uso endovenoso de ácido tranexâmico na artroplastia total de joelho sem uso de torniquete

Abstract Objective: To identify blood transfusion requirements and postoperative complications in patients undergoing total knee arthroplasty (TKA) with no tourniquet and intraoperative intravenous administration of tranexamic acid. Methods: This retrospective observational study analyzed 49 preopeative and postoperative medical records of patients undergoing TKA. A paired t-test compared changes in hemoglobin (HB) and packed cell volume (PCV), and an independent t-test with Welch correction compared HB and PCV changes between genders. A Spearman correlation test determined associations between age and days of postoperative hospitalization with HB and PCV changes. The significance level adopted was p < 0.05. Results: The patients' mean age was 71.9 ± 6.7 years; most subjects were women (73.5%). The right side (59.2%) was the most affected. Only one participant required a blood transfusion, while three subjects had complications during the postoperative follow-up. No patient had a thromboembolic event. The median length of postoperative hospital stay was 2 days (interquartile range [IQR] = 1.0). There were reductions in HB and PCV levels between the pre-operative and postoperative period, and female patients had a higher HB reduction. Conclusion: TKA with tranexamic acid and no tourniquet did not cause significant postoperative complications or require blood transfusions.

Resumo Objetivo: Identificar a necessidade de transfusão sanguínea e intercorrências inerentes ao pós-operatório de pacientes submetidos à artroplastia total de joelho (ATJ), a partir de manejos realizados sem o uso de torniquete e com administração de ácido tranexâmico endovenoso intra-operatório. Métodos: Trata-se de um estudo observacional retrospectivo, a partir da observação de 49 prontuários médicos de pacientes submetidos à ATJ em pré e pós-operatório. Foi utilizado o teste t pareado para fazer comparações das modificações de hemoglobina (HB) e hematócrito (HT) e o teste t independente com correção de Welch para comparar as modificações de HB e HT entre os sexos. As associações de idade e dias de internação no pós-operatório com as modificações de HB e HT foram testadas pela correlação de Spearman. O nível de significância adotado foi p < 0,05. Resultados: Os pacientes apresentaram idade média de 71,9 ± 6,7 anos. A maioria da amostra foi composta por mulheres (73,5%) e o lado direito (59,2%) foi o mais acometido. Apenas um participante necessitou de transfusão de sangue e três participantes apresentaram intercorrências durante o seguimento pós-operatório. Nenhum paciente apresentou evento tromboembólico. A mediana da duração da internação no pós-operatório foi de dois dias (IIQ= 1,0). Verificaram-se reduções nas dosagens de HB e HT entre o pré e pós-operatório, e pacientes do sexo feminino apresentaram maior redução de HB. Conclusão: ATJ com uso de ácido tranexâmico e sem uso de torniquete não acarretou complicações pós-operatórias ou necessidade de transfusão sanguínea significativas.

[Translated article] The efficacy of topical tranexamic acid in reverse shoulder arthroplasty.

INTRODUCTION: Topical tranexamic acid (TXA) has been shown to decrease blood loss in knee and hip arthroplasty. Despite there is evidence about its effectiveness when administered intravenous, its effectiveness and optimal dose when used topically have not been established. We hypothesised that the use of 1.5g (30mL) of topical TXA could decrease the amount of blood loss in patients after reverse total shoulder arthroplasty (RTSA). MATERIAL AND METHODS: One hundred and seventy-seven patients receiving a RSTA for arthropathy or fracture were retrospectively reviewed. Preoperative-to-postoperative change in haemoglobin (ΔHb) and hematocrit (ΔHct) level drain volume output, length of stay and complications were evaluated for each patient. RESULTS: Patients receiving TXA has significant less drain output in both for arthropathy (ARSA) (104 vs. 195mL, p=0.004) and fracture (FRSA) (47 vs. 79mL, p=0.01). Systemic blood loss was slightly lower in TXA group, but this was not statistically significant (ARSA, ΔHb 1.67 vs. 1.90mg/dL, FRSA 2.61 vs. 2.7mg/dL, p=0.79). This was also observed in hospital length of stay (ARSA 2.0 vs. 2.3 days, p=0.34; 2.3 vs. 2.5, p=0.56) and need of transfusion (0% AIHE; AIHF 5% vs. 7%, p=0.66). Patients operated for a fracture had a higher rate of complications (7% vs. 15.6%, p=0.04). There were no adverse events related to TXA administration. CONCLUSION: Topical use of 1.5g of TXA decreases blood loss, especially on the surgical site without associated complications. Thus, haematoma decrease could avoid the systematic use of postoperative drains after reverse shoulder arthroplasty.

The efficacy of topical tranexamic acid in reverse shoulder arthroplasty. / Eficacia del ácido tranexámico tópico en la artroplastia invertida de hombro.

INTRODUCTION: Topical tranexamic acid (TXA) has been shown to decrease blood loss in knee and hip arthroplasty. Despite there is evidence about its effectiveness when administered intravenous, its effectiveness and optimal dose when used topically has not been established. We hypothesized that the use of 1.5g (30mL) of topical TXA could decrease the amount of blood loss in patients after reverse total shoulder arthroplasty (RTSA). MATERIAL AND METHODS: One hundred and seventy-seven patients receiving a RSTA for arthropathy or fracture were retrospectively reviewed. Preoperative-to-postoperative change in hemoglobin (ΔHb) and hematocrit (ΔHct) level drain volume output, length of stay and complications were evaluated for each patient. RESULTS: Patients receiving TXA has significant less drain output in both for arthropathy (ARSA) (104 vs. 195mL, p=0.004) and fracture (FRSA) (47 vs. 79mL, p=0.01). Systemic blood loss was slightly lower in TXA group, but this was not statistically significant (ARSA, ΔHb 1.67 vs. 1.90mg/dL, FRSA 2.61 vs. 2.7mg/dL, p=0.79). This was also observed in hospital length of stay (ARSA 2.0 vs. 2.3 days, p=0.34; 2.3 vs. 2.5, p=0.56) and need of transfusion (0% AIHE; AIHF 5% vs. 7%, p=0.66). Patients operated for a fracture had a higher rate of complications (7% vs. 15.6%, p=0.04). There were no adverse events related to TXA administration. CONCLUSION: Topical use of 1.5g of TXA decreases blood loss, especially on the surgical site without associated complications. Thus, hematoma decrease could avoid the systematic use of postoperative drains after reverse shoulder arthroplasty.

Comparison of Blood Loss with the Use of Intravenous and Intraarticular Tranexamic Acid Versus Isolated Intraarticular in Primary Knee Arthroplasty / Comparação da perda sanguínea com a utilização do ácido tranexâmico endovenoso e intra-articular versus intra-articular isolado em artroplastia primária de joelho

Abstract Objective The objective of this work is to compare blood loss during primary knee arthroplasty with the use of intravenous and intraarticular (IV + IA) tranexamic acid versus intraarticular (IA) tranexamic acid alone. Methods This is a randomized, double-blind clinical trial. Patients with indication for primary total knee arthroplasty were recruited in a specialized clinic, where they were operated by the same surgeon, always using the same surgical technique. Thirty patients were allocated in the IV + IA tranexamic acid group and 30 patients in the IA tranexamic acid group, according to randomization. Blood loss was compared through hemoglobin, hematocrit, drain volume, and blood loss estimation (Gross and Nadler calculus). Results After collection, data from 40 patients were analyzed, 22 in the IA group and 18 in the IV +IA group. There were 20 losses due to collection error. Between groups IA and IV + IA, there were no significant differences in 24 hours between hemoglobin levels (10.56 vs. 10.65 g/dL; F1.39 = 0.63, p =0.429), erythrocyte (3.63 vs. 3.73 million/mm³; F1.39 = 0.90, p = 0.346); hematocrit (32.14 vs. 32.60%; F1.39 = 1.39, p = 0.240); drainage volume (197.0 vs. 173.6 mL; F1.39 = 3.38 p = 0.069); and estimated blood loss (1,002.5 vs. 980.1; F1.39 =0.09, p = 0.770). The same occurred in comparisons conducted after 48 hours postoperatively. Time was a significant factor for the change of all outcome variables. However, the treatment did not modify the effect of time on these outcomes. No individual presented any thromboembolic event during the work period. Conclusions The use of IV + IA tranexamic acid showed no advantage in reducing blood loss when compared to the use of IA tranexamic acid alone in primary knee arthroplasties. This technique proved to be safe, since no thromboembolic event occurred during the development of the work.

Resumo Objetivo O objetivo desse trabalho é comparar a perda sanguínea durante a artroplastia primária de joelho, com a utilização do ácido tranexâmico endovenoso e intra-articular (EV + IA) versus intra-articular (IA) isolado. Métodos Trata-se de um ensaio clínico randomizado, duplo cego. Pacientes com indicação de artroplastia total primária de joelho foram captados em clínica especializada, onde foram operados pelo mesmo cirurgião, utilizando sempre a mesma técnica cirúrgica. Trinta pacientes foram alocados no grupo ácido tranexâmico EV + IA e 30 pacientes, no grupo IA, conforme randomização. Foi comparada a perda sanguínea através dos níveis de hemoglobina, hematócrito, volume do dreno e estimativa da perda sanguínea (EBL) (cálculo de Gross e Nadler). Resultados Após a coleta, foram analisados os dados de 40 pacientes, sendo 22 do grupo IA isolado e 18 do grupo EV + IA. Ocorreram 20 perdas por erro de coleta. Entre os grupos IA e EV + IA, não ocorreram diferenças significativas em 24 horas entre os níveis de hemoglobina (10,56 vs. 10,65 g/dL; F1,39 =0,63, p = 0,429), eritrócito (3,63 vs. 3,73 milhões/mm3; F1,39 = 0,90, p =0,346), hematócrito (32,14 vs. 32,60%; F1,39 = 1,39; p=0,240), volume de dreno (197,0 vs. 173,6 mL; F1,39 = 3,38; p =0,069) e estimativa de perda sanguínea (EBL) (1.002,5 vs. 980,1; F1,39 = 0,09; p =0,770). O mesmo ocorreu nas comparações realizadas 48 horas pós-operatório. O tempo foi fator significativo para a mudança de todas as variáveis de desfecho. Porém, o tratamento não modificou o efeito do tempo nesses desfechos. Nenhum indivíduo apresentou qualquer evento tromboembólico durante o período do trabalho. Conclusões O uso do ácido tranexâmico EV + IA não demonstrou vantagem em redução de perda sanguínea quando comparado ao uso de ácido tranexâmico IA isolado nas artroplastias primárias de joelho. Esta técnica demonstrou-se segura, visto que nenhum evento trombo-embólico ocorreu durante o desenvolvimento do trabalho.

The Efficacy of Topical Tranexamic Acid in Femoral Neck Fractured Patients Undergoing Cemented Bipolar Hemiarthroplasty: A Randomized Double Blinded Controlled Trial / A eficácia do ácido tranexâmico tópico em pacientes com fraturas no pescoço femoral submetidos a hemiartroplastia bipolar cimentada: Um ensaio controlado duplo-cego randomizado

Abstract Objective Tranexamic acid (TXA) is an antifibrinolytic that is widely used for decreasing blood loss and blood transfusion rates in total hip arthroplasty. However, there is limited evidence of topical TXA usage in hip hemiarthroplasty for femoral neck fractures. The present study aimed to evaluate the effects of topical TXA on blood loss and on blood transfusions in femoral neck fracture patients who underwent cemented bipolar hemiarthroplasty. Methods Twenty-six patients with femoral neck fractures who were scheduled for bipolar cemented arthroplasty were randomized into two groups. The first group of 12 patients received topical TXA during their operation, whereas 14 patients in the second group received a placebo. Hematocrit was measured at 6 and 24 hours postoperatively. Blood transfusions and postoperative complications were also recorded. Results Total blood loss was not different between the TXA group and the control group (TXA group: 459.48 ± 456.32 ml, and control group: 732.98 ± 474.02 ml; p = 0.14). However, there were no patients within the TXA group who required a blood transfusion, while there were 4 patients in the control group who received allogenic blood transfusions (p = 0.044). There were no postoperative complications, such as wound complication, venous thromboembolism, or cardiovascular complications within either group. Conclusion Topical TXA could not decrease total blood loss but was able to reduce transfusion rates in patients who underwent cemented bipolar hip hemiarthroplasty in femoral neck fractures. Further studies in doses of topical TXA in a larger sample size would be beneficial. Level of Evidence II.

Resumo Objetivo O ácido tranexâmico (TXA) é um antifibrinolítico amplamente utilizado para diminuir as taxas de perda de sangue e de transfusão de sangue na artroplastia total do quadril. No entanto, há evidências limitadas de uso tópico de TXA na hemiartroplastia do quadril para fraturas no pescoço femoral. O presente estudo teve como objetivo avaliar os efeitos do TXA tópico na perda de sangue e transfusões de sangue em pacientes com fratura femoral que foram submetidos a hemiartroplastia bipolar cimentada. Métodos Vinte e seis pacientes com fraturas no pescoço femoral e programados para artroplastia cimentada bipolar foram randomizados em dois grupos. O primeiro grupo de 12 pacientes recebeu TXA tópico durante a operação; no segundo grupo, 14 pacientes receberam placebo. O hematócrito foi medido às 6 e 24 horas no pósoperatório. Também foram registradas transfusões de sangue e complicações pósoperatórias. Resultados A perda total de sangue não foi diferente entre o grupo TXA e o grupo controle (grupo TXA: 459,48 ±456,32 ml; e grupo controle: 732,98 ±474,02 ml; p = 0,14). No entanto, não houve pacientes dentro do grupo TXA que necessitaram de transfusão de sangue, enquanto 4 pacientes no grupo controle fizeram transfusões de sangue halogênicas (p = 0,044). Não houve complicações pós-operatórias, tais como complicação da ferida, tromboembolismo venoso ou complicações cardiovasculares dentro de qualquer grupo. Conclusão O TXA tópico não conseguiu diminuir a perda total de sangue, mas foi capaz de reduzir as taxas de transfusão, em pacientes submetidos a hemiartroplastia de quadril bipolar cimentada em fraturas no pescoço femoral. Outros estudos com doses de TXA tópico em um tamanho amostral maior seriam benéficos. Nível de Evidência II.

Uso do ácido tranexâmico em usuários atendidos no serviço pré-hospitalar aéreo público do distrito federal / Use of tranexamic acid in users served in federal district public air pre-hospital service

Objective: to analyze the use of tranexamic acid (TXA) in the pre-hospital public air service in the Federal District. Method: descriptive study with cross-sectional design and quantitative approach. The study encompasses the documentary analysis of secondary data from the electronic medical records and attendance sheets of the Aeromedical Service (SA) of the Federal District (DF). Results: There was a reduction in the degree of shock and improvement in hemodynamic parameters from the Pre-Hospital (APH) to the in-hospital moment after using TXA. Conclusion: it was observed in the present study that the use of TXA associated with other hemorrhage control measures proved to be effective in improving the hemodynamic condition of patients. Volemic resuscitation of patients in the pre-hospital period and other measures to contain bleeding proved to be effective for resuscitation in severe degrees of shock. The administration of TXA in the APH occurred in the 1st hour of care with a dosage of 1g, with improvement.(AU)

Objetivo:analisar o uso do ácido tranexâmico (TXA) no serviço pré-hospitalar aéreo público do Distrito Federal. Método: estudo descritivo com delineamento transversal e abordagem. O estudo engloba a análise documental de dados secundários provenientes dos prontuários eletrônicos e fichas de atendimento do Serviço Aeromédico (SA) do Distrito Federal (DF). Resultados: O correu redução no grau de choque e melhora dos parâmetros hemodinâmicos do momento Pré-Hospitalar (APH) para o intra-hospitalar após uso do TXA. Conclusão: observou-se no presente estudo que o uso do TXA associado a outras medidas de controle de hemorragia mostrou-se eficaz para melhora da condição hemodinâmica dos pacientes. A reposição volêmica dos pacientes ainda no período pré-hospitalar e demais medidas para contenção de hemorragia mostraram-se efetiva para reanimação em graus severos de choque. A administração do TXA no APH ocorreu na 1ª hora do atendimento com dosagem de 1g com melhora nos dos parâmetros clínicos.(AU)

Objetivo: analizar el uso del ácido tranexámico (TXA) en el servicio público aéreo prehospitalario en el Distrito Federal. Método: estudio descriptivo con diseño transversal y enfoque cuantitativo. El estudio abarca el análisis documental de datos secundarios de las historias clínicas electrónicas y planillas de asistencia del Servicio Aeromédico (SA) del Distrito Federal (DF). Resultados: Hubo una reducción en el grado de shock y mejoría en los parámetros hemodinámicos desde el momento Pre-Hospitalario (HAP) hasta el intrahospitalario después de utilizar ATX. Conclusión: se observó en el presente estudio que el uso de ATX asociado a otras medidas de control de la hemorragia demostró ser eficaz en la mejoría del estado hemodinámico de los pacientes. La reanimación volémica de pacientes en el período prehospitalario y otras medidas para contener el sangrado demostraron ser efectivas para la reanimación en grados severos de shock. La administración de TXA en el HAP se produjo en la 1ª hora de atención con dosis de 1g, con mejoría de los parámetros clínicos.(AU)

Uso do ácido tranexâmico em usuários atendidos no serviço pré-hospitalar aéreo público do distrito federal / Uso de ácido tranexámico en usuarios atentidos en servicio prehospitalario del aire píblico del distrito federal / Use of tranexamic acid in users served in federal district public air pre-hospital service

Objetivo:analisar o uso do ácido tranexâmico (TXA) no serviço pré-hospitalar aéreo público do Distrito Federal. Método: estudo descritivo com delineamento transversal e abordagem. O estudo engloba a análise documental de dados secundários provenientes dos prontuários eletrônicos e fichas de atendimento do Serviço Aeromédico (SA) do Distrito Federal (DF). Resultados: O correu redução no grau de choque e melhora dos parâmetros hemodinâmicos do momento Pré-Hospitalar (APH) para o intra-hospitalar após uso do TXA. Conclusão: observou-se no presente estudo que o uso do TXA associado a outras medidas de controle de hemorragia mostrou-se eficaz para melhora da condição hemodinâmica dos pacientes. A reposição volêmica dos pacientes ainda no período pré-hospitalar e demais medidas para contenção de hemorragia mostraram-se efetiva para reanimação em graus severos de choque. A administração do TXA no APH ocorreu na 1ª hora do atendimento com dosagem de 1g com melhora nos dos parâmetros clínicos.(AU)

Objective: to analyze the use of tranexamic acid (TXA) in the pre-hospital public air service in the Federal District. Method: descriptive study with cross-sectional design and quantitative approach. The study encompasses the documentary analysis of secondary data from the electronic medical records and attendance sheets of the Aeromedical Service (SA) of the Federal District (DF). Results: There was a reduction in the degree of shock and improvement in hemodynamic parameters from the Pre-Hospital (APH) to the in-hospital moment after using TXA. Conclusion: it was observed in the present study that the use of TXA associated with other hemorrhage control measures proved to be effective in improving the hemodynamic condition of patients. Volemic resuscitation of patients in the pre-hospital period and other measures to contain bleeding proved to be effective for resuscitation in severe degrees of shock. The administration of TXA in the APH occurred in the 1st hour of care with a dosage of 1g, with improvement in the clinical parameters.(AU)

Objetivo: analizar el uso del ácido tranexámico (TXA) en el servicio público aéreo prehospitalario en el Distrito Federal. Método: estudio descriptivo con diseño transversal y enfoque cuantitativo. El estudio abarca el análisis documental de datos secundarios de las historias clínicas electrónicas y planillas de asistencia del Servicio Aeromédico (SA) del Distrito Federal (DF). Resultados: Hubo una reducción en el grado de shock y mejoría en los parámetros hemodinámicos desde el momento Pre-Hospitalario (HAP) hasta el intrahospitalario después de utilizar ATX. Conclusión: se observó en el presente estudio que el uso de ATX asociado a otras medidas de control de la hemorragia demostró ser eficaz en la mejoría del estado hemodinámico de los pacientes. La reanimación volémica de pacientes en el período prehospitalario y otras medidas para contener el sangrado demostraron ser efectivas para la reanimación en grados severos de shock. La administración de TXA en el HAP se produjo en la 1a hora de atención con dosis de 1g, con mejoría de los parámetros clínicos(AU)

Patient Blood Management en ginecología / Patient Blood Management in gynaecology

El Patient Blood Management (PBM) es un enfoque centrado en el paciente, sistemático y basado en la evidencia, destinado a mejorar los resultados de las pacientes mediante el manejo y la preservación de la propia sangre. Consta de tres pilares clásicos que se llevan a cabo de forma multidisciplinar y multimodal: optimización de la masa eritrocitaria, reducción de la hemorragia y mejoría de la tolerancia a la anemia. La optimización de la masa eritrocitaria incluye el diagnóstico precoz de la anemia y su tratamiento con hierro (oral o intravenoso), siendo el déficit de hierro la causa más frecuente de anemia en el contexto de sangrado uterino anómalo (SUA). La reducción de la hemorragia incluye estrategias destinadas a tratar la causa del SUA, sea de forma quirúrgica, médica o ambas. La mejoría en la tolerancia a la anemia incluye el umbral de transfusión restrictivo en pacientes sin hemorragia activa, administrando el mínimo número de unidades de hematíes para paliar los síntomas (Single Unit Transfusion). En el presente texto se realiza una revisión de la evolución y de la situación actual del PBM en sus tres pilares, centrándose en los aspectos concretos más directamente aplicables al sangrado uterino anómalo.(AU)

Patient Blood Management (PBM) is a systematic, evidence-based, patient-centred approach aimed at improving patient outcomes through the management and preservation of their own blood. It consists of three classic pillars performed in a multidisciplinary and multimodal way: optimization of erythrocyte mass, reduction of haemorrhage, and improvement of tolerance to anaemia. Optimization of erythrocyte mass includes the early diagnosis of anaemia and its treatment with iron (oral or intravenous), with iron deficiency being the most frequent cause of anaemia in the context of abnormal uterine bleeding (AUB). Bleeding reduction includes strategies aimed at treating the cause of AUB either surgically, medically, or both. The improvement in tolerance to anaemia includes the restrictive transfusion threshold in patients without active bleeding, administering the minimum number of red blood cell units to alleviate symptoms (single unit transfusion). This text reviews the evolution and current situation of the three pillars of PBM, focusing on the specific aspects most directly applicable to abnormal uterine bleeding.(AU)

Comparación entre la administración endovenosa y la administración periarticular de ácido tranexámico en cirugía de reemplazo total de rodilla: estudio de dos cohortes consecutivas / Comparison between intravenous and periarticular administration of tranexamic acid in total knee replacement surgery: a study of two consecutive cohorts

Introducción. Se ha reportado que el ácido tranexámico (AT) es útil en el manejo del sangrado posoperatorio de pacientes sometidos a artroplastia total de rodilla (ATR), pero no hay consenso sobre su dosificación y vía de administración. Objetivo. Evaluar y comparar la eficacia para reducir el sangrado posoperatorio de la administración endovenosa y la administración periarticular de AT en pacientes sometidos a ATR. Metodología. Estudio observacional realizado con 72 pacientes operados entre 2021 y 2022 en un centro hospitalario de segundo nivel de atención en Barcelona (España). Los pacientes se dividieron en 2 grupos según la vía de administración del AT (grupo 1: administración endovenosa de dos dosis, una intraoperatoria de 15mg/kg y una posoperatoria de 10mg/kg; grupo 2: una infiltración periarticular de 2g). Se realizó un análisis bivariado con la prueba t de Student para evaluar las diferencias entre grupos. Resultados. El promedio de edad fue 73,72 años en el grupo 1 y 72,96 años en el grupo 2. Se observó una disminución en los niveles de hemoglobina preoperatorio y a las 24 horas en ambos grupos (grupo 1: 2,1 mg/dL; grupo 2: 2,14 mg/dL). En el grupo 2, un paciente presentó embolia pulmonar y otro requirió de transfusión de glóbulos rojos. Conclusiones. El uso de AT, tanto por vía endovenosa como en administración local, permite reducir el sangrado posoperatorio en pacientes sometidos a ATR. No se evidenciaron diferencias estadísticamente significativas en la disminución de los niveles de hemoglobina posoperatorios entre los grupos.

Introduction: Tranexamic acid (TA) has been reported as useful in the management of postoperative bleeding in patients undergoing total knee arthroplasty (TKA), but there is no consensus on its dosage and route of administration. Objective: To evaluate and compare the efficacy of intravenous and periarticular administration of TA in patients undergoing TKA to reduce postoperative bleeding.Methodology: Observational study conducted with 72 patients operated on between 2021 and 2022 in a secondary care center in Barcelona (Spain). Patients were divided into 2 groups depending on the route of TA administration (group 1: intravenous administration of two doses, an intraoperative dose of 15mg/kg and a postoperative dose of 10mg/kg; group 2: periarticular infiltration of 2g). A bivariate analysis was performed using Student's t-test to evaluate the differences between groups.Results: The mean age of the patients was 73.72 years in group 1 and 72.96 years in group 2. A decrease in preoperative and 24-hour hemoglobin levels was observed in both groups (group 1: 2.1 mg/dL; group 2: 2.14 mg/dL). One patient in group 2 presented pulmonary embolism and another required red blood cell transfusion.Conclusions: The use of TA, both intravenous and locally administered, reduces postoperative bleeding in patients undergoing TKA. There were no statistically significant differences in the decrease of postoperative hemoglobin levels between groups

Tranexamic acid in adolescent scoliosis surgery: a systematic review / ácido tranexâmico na cirurgia de escoliose em adolescentes: revisão sistemática / ácido tranexámico en la cirugía de escoliosis en adolescentes: revisión sistemática

ABSTRACT: The objective of this study was to conduct a systematic literature review to evaluate the impact of perioperative blood loss reduction and blood transfusion rate in patients undergoing adolescent idiopathic scoliosis correction surgery and to correlate these results with the different doses of tranexamic acid used in the literature. Ten databases (BVS, COCHRANE, EBSCOHOST, EMBASE, EPISTEMONIKOS, PROQUEST, PUBMED PMC, PUBMED, SCOPUS, WEB OF SCIENCE) were searched to find studies on the effectiveness of tranexamic acid in idiopathic scoliosis surgery. The mean differences in bleeding and transfusions were combined using a random-effects meta-analysis. A total of 17 studies with 1608 patients were included in the evaluation, demonstrating an Odds Ratio of 2.8 (95% CI: 0.8-4.3) as a measure of association for the risk of bleeding and transfusion in the control group (non-users of tranexamic acid), efficiency in reducing bleeding (p=0.03). Additionally, a mean reduction in bleeding of approximately 700 ml was observed. There was no statistical difference between the doses used. The systematic review showed that tranexamic acid effectively reduces bleeding and the need for transfusions, but there were no significant differences in the results between different doses of tranexamic acid. Level of Evidence II; Systematic Review.

RESUMO: O Objetivo desse estudo foi realizar uma revisão sistemática da literatura com finalidade de avaliar o impacto da redução de sangramento perioperatório e taxa de transfusão sanguínea em pacientes submetidos a cirurgia de correção de escoliose idiopática do adolescente, e correlacionar esses resultados com as diferentes doses de ácido tranexâmico utilizadas na literatura. Foram pesquisados dez bancos de dados BVS, COCHRANE, EBSCOHOST, EMBASE, EPISTEMONIKOS, PROQUEST, PUBMED PMC, PUBMED, SCOPUS, WEB OF SCIENCE para encontrar estudos sobre a eficácia do ácido tranexâmico em cirurgia de escoliose idiopática. As diferenças médias de sangramento e transfusões foram combinadas usando uma meta-análise de efeito aleatório. Um total de 17 estudos com 1608 pacientes foi incluso na avaliação. Demonstrando Odds Ratio 2,8 (95% IC: 0,8-4,3) como medida de associação para risco de sangramento e transfusão no grupo de pacientes controle (não usuários de ácido tranexâmico), eficiência na redução de sangramento (p = 0,03). Ainda, verificou-se uma redução média no sangramento de aproximadamente 700 ml. Não houve diferença estatísticas entre as doses utilizadas. A revisão sistemática mostrou que o ácido tranexâmico é eficaz na redução do sangramento e na necessidade de transfusões, mas não houve diferenças significativas nos resultados entre diferentes doses de ácido tranexâmico. Nível de Evidência II; Revisão Sistemática.

RESUMEN: El objetivo de este estudio fue realizar una revisión sistemática de la literatura con el fin de evaluar el impacto de la reducción del sangrado perioperatorio y la tasa de transfusión sanguínea en pacientes sometidos a cirugía de corrección de escoliosis idiopática en adolescentes, y correlacionar estos resultados con las diferentes dosis de ácido tranexámico utilizadas en la literatura. Se investigó en diez bases de datos: BVS, COCHRANE, EBSCOHOST, EMBASE, EPISTEMONIKOS, PROQUEST, PUBMED PMC, PUBMED, SCOPUS y WEB OF SCIENCE para encontrar estudios sobre la eficacia del ácido tranexámico en la cirugía de escoliosis idiopática. Las diferencias medias de sangrado y transfusiones se combinaron utilizando un metaanálisis de efectos aleatorios. Un total de 17 estudios con 1608 pacientes fue incluido en la evaluación, demostrando una Odds Ratio de 2,8 (IC del 95%: 0,8-4,3) como medida de asociación para el riesgo de sangrado y transfusión en el grupo de control (no usuarios de ácido tranexámico) y eficacia en la reducción del sangrado (p = 0,03). Además, se observó una reducción promedio en el sangrado de aproximadamente 700 ml. No se observaron diferencias estadísticas entre las dosis utilizadas. La revisión sistemática mostró que el ácido tranexámico es efectivo en la reducción del sangrado y la necesidad de transfusiones, pero no hubo diferencias significativas en los resultados entre las diferentes dosis de ácido tranexámico. Level of Evidence II; Systematic Review.

Versatilidad terapéutica del ácido tranexámico aplicado a la Cirugía Plástica. Revisión bibliográfica / Therapeutic versatility of tranexamic acid applied to Plastic Surgery. Bibliographic review

Introducción y objetivo: Son múltiples los cuidados perioperatorios para prevenir complicaciones, desde la adecuada selección del paciente hasta el uso de medicamentos para disminuir las pérdidas sanguíneas en el transoperatorio. La tendencia actual es prevenir antes que tratar y en múltiples cirugías se ha ensayado el ácido tranexámico con fines de ahorro de sangre, reducción de la equimosis e inflamación, y como despigmentante. Realizamos la presente investigación con el objetivo de mostrar la utilidad del ácido tranexámico e incrementar su uso en Cirugía Plástica para disminuir la pérdida sanguínea transoperatoria y como tratamiento de la hiperpigmentación, en pro de garantizar una mayor seguridad al paciente. Material y método: Revisión bibliográfica en Pubmed, Elsevier, Google Académico, Research y Scielo; artículos en inglés y español utilizando tres estrategias de búsqueda mediante combinación de descriptores con operadores booleanos, limitando el “AND” para términos diferentes y el “OR” para homólogos, entre 1968 y 2022. Resultados: A través del conocimiento de la farmacocinética del ácido tranexámico comprobamos que, además de su utilidad en la prevención del sangrado, a partir de la inhibición del complemento y de la síntesis de melanina tiene también utilidad demostrada como despigmentante en la hipercromía. Conclusiones: Este estudio contribuye a conocer mejor las utilidades del ácido tranexámico para prevenir el sangrado en la cirugía y como despigmentante cutáneo. Consideramos que este último aspecto abre una puerta de estudio de su aplicación en el tratamiento de la hiperpigmentación producida en la alogenosis iatrogénica, utilidad que se sumaría a las ya conocidas. (AU)

Background and objective: There are multiple perioperative cares to prevent complications, from the proper selection of the patient to the use of medications to reduce blood loss during the transoperative period. The current trend is to prevent rather than treat, and tranexamic acid has been tested in multiple surgeries for purposes of saving blood, reducing ecchymosis and inflammation, and as a depigmentation agent. We carried out this research with the objective of showing the usefulness of tranexamic acid and increasing its use in Plastic Surgery to reduce intraoperative blood loss and as a treatment for hyperpigmentation, in order to guarantee greater patient safety. Methods: Literature review in Pubmed, Elsevier, Google Scholar, Research and Scielo; articles in English and Spanish using three search strategies by combining descriptors with boolean operators, limiting the "AND" for different terms and the "OR" for homologues, between 1968 and 2022. Results: Through the knowledge of the pharmacokinetics of tranexamic acid, we verified that, in addition to its usefulness in the prevention of bleeding, through the inhibition of complement and melanin synthesis it has also been shown to be useful as a depigmenting agent in hyperchromia. Conclusions: This study contributes to better understand the benefits of tranexamic acid to prevent bleeding in surgery and as a skin depigmentation agent. We believe that this last aspect opens a door for the study of its application in the treatment of hyperpigmentation produced in iatrogenic allogeneic disease, a utility that would be added to those already known. (AU)

Ensayo clínico aleatorizado, controlado con placebo y doble ciego para evaluar la eficacia y la seguridad del ácido tranexámico tópico en el ahorro de pérdidas sanguíneas en pacientes tratados mediante cirugía protésica de rodilla / Randomized, placebo-controlled, double-blind clinical trial to evaluate efficacy and safety of topical tranexamic acid in saving blood loss in patients undergoing prosthetic knee surgery

Antecedentes y objetivo: Durante la artroplastia de rodilla se produce una pérdida sanguínea importante. El objetivo de nuestro estudio es valorar la eficacia y la seguridad de la administración tópica de 3 g de ácido tranexámico (TXA) en cuanto a la reducción de pérdidas sanguíneas en artroplastia de rodilla. Material y método: Se ha realizado un ensayo clínico aleatorizado, fase iii, doble ciego, controlado con placebo. Se incluyó a 150 pacientes en 2grupos paralelos de tratamiento (75 por brazo). La solución se administró de forma tópica intraarticular tras la cementación y previo al cierre capsular. Se realizaron determinaciones analíticas antes y después de la cirugía. Resultados: La pérdida total de sangre media para el grupo placebo fue de 831,5ml y 662,3ml para el grupo TXA con una diferencia entre ambos de 169,2ml, lo que supone un ahorro del 20,4%, siendo estadísticamente significativa (p<0,001). No se obtuvieron diferencias en el inicio de la deambulación, días de ingreso o escala visual analógica al mes de la cirugía. Se retiró a 10pacientes por infección del tracto urinario prequirúrgico, alergia a metales, fallo de selección, debilitamiento rotuliano, inestabilidad protésica, fractura tibial intraquirúrgica, cambio de indicación a prótesis unicompartimental y una pérdida de seguimiento. Hubo una única complicación no relacionada con el fármaco (globos vesicales de repetición). Conclusión: La administración de TXA de forma tópica tras la cementación de los componentes protésicos en artroplastia de rodilla en una única dosis demuestra que es segura y eficaz.(AU)

Background and objective: Knee arthroplasty is a major surgery with potential significant blood loss. Assess the efficacy and safety of topical administration of 3g of tranexamic acid (TXA) in terms of reducing blood loss in knee arthroplasty. Material and method: A randomized, phase III, double-blind, placebo-controlled clinical trial has been conducted. We included 150 patients in 2parallel treatment groups (75 per arm). The solution was administered topically intra-articular after cementation and prior to capsular closure. Analytical determinations were made before and after surgery to quantify blood loss. Results: Total blood loss for the placebo group was 831.5ml and 662.3ml for the TXA group. The difference between the 2groups was 169.2ml; which means a save of 20.4 per cent; this difference being statistically significant (P<.001). There were no differences in terms of the onset of ambulation, days of admission or Visual Analogue Scale at one month of surgery. Ten patients were rejected for presurgical urinary tract infection, metal allergy, selection failure, patellar weakening, prosthetic instability, intrasurgical tibial fracture, change of indication to unicompartimental prosthesis and a loss of follow-up. There was only one complication unrelated to the investigational drug (bladder balloon). Conclusion: The administration of TXA topically after cementation of the prosthetic components in total knee arthroplasty in a single dose has demonstrated being safe and effective.(AU)

[Translated article] Randomized, placebo-controlled, double-blind clinical trial to evaluate efficacy and safety of topical tranexamic acid in saving blood loss in patients undergoing prosthetic knee surgery / Ensayo clínico aleatorizado, controlado con placebo y doble ciego para evaluar la eficacia y la seguridad del ácido tranexámico tópico en el ahorro de pérdidas sanguíneas en pacientes tratados mediante cirugía protésica de rodilla

Antecedentes y objetivo: Durante la artroplastia de rodilla se produce una pérdida sanguínea importante. El objetivo de nuestro estudio es valorar la eficacia y la seguridad de la administración tópica de 3 g de ácido tranexámico (TXA) en cuanto a la reducción de pérdidas sanguíneas en artroplastia de rodilla. Material y método: Se ha realizado un ensayo clínico aleatorizado, fase iii, doble ciego, controlado con placebo. Se incluyó a 150 pacientes en 2grupos paralelos de tratamiento (75 por brazo). La solución se administró de forma tópica intraarticular tras la cementación y previo al cierre capsular. Se realizaron determinaciones analíticas antes y después de la cirugía. Resultados: La pérdida total de sangre media para el grupo placebo fue de 831,5ml y 662,3ml para el grupo TXA con una diferencia entre ambos de 169,2ml, lo que supone un ahorro del 20,4%, siendo estadísticamente significativa (p<0,001). No se obtuvieron diferencias en el inicio de la deambulación, días de ingreso o escala visual analógica al mes de la cirugía. Se retiró a 10pacientes por infección del tracto urinario prequirúrgico, alergia a metales, fallo de selección, debilitamiento rotuliano, inestabilidad protésica, fractura tibial intraquirúrgica, cambio de indicación a prótesis unicompartimental y una pérdida de seguimiento. Hubo una única complicación no relacionada con el fármaco (globos vesicales de repetición). Conclusión: La administración de TXA de forma tópica tras la cementación de los componentes protésicos en artroplastia de rodilla en una única dosis demuestra que es segura y eficaz.(AU)

Background and objective: Knee arthroplasty is a major surgery with potential significant blood loss. Assess the efficacy and safety of topical administration of 3g of tranexamic acid (TXA) in terms of reducing blood loss in knee arthroplasty. Material and method: A randomized, phase III, double-blind, placebo-controlled clinical trial has been conducted. We included 150 patients in 2parallel treatment groups (75 per arm). The solution was administered topically intra-articular after cementation and prior to capsular closure. Analytical determinations were made before and after surgery to quantify blood loss. Results: Total blood loss for the placebo group was 831.5ml and 662.3ml for the TXA group. The difference between the 2groups was 169.2ml; which means a save of 20.4 per cent; this difference being statistically significant (P<.001). There were no differences in terms of the onset of ambulation, days of admission or Visual Analogue Scale at one month of surgery. Ten patients were rejected for presurgical urinary tract infection, metal allergy, selection failure, patellar weakening, prosthetic instability, intrasurgical tibial fracture, change of indication to unicompartimental prosthesis and a loss of follow-up. There was only one complication unrelated to the investigational drug (bladder balloon). Conclusion: The administration of TXA topically after cementation of the prosthetic components in total knee arthroplasty in a single dose has demonstrated being safe and effective.(AU)

Ensayo clínico para determinar si el momento de administración del ácido tranexámico en la cirugía de prótesis total de rodilla con torniquete influye en el sangrado perioperatorio / Clinical trial to determine whether the timing of tranexamic acid administration influences perioperative bleeding in total knee arthroplasty

Antecedentes y objetivos: El momento óptimo para la administración de ácido tranexámico en la artroplastia de rodilla con torniquete no está claro. El objetivo principal de nuestro estudio era demostrar si su administración tras la inducción anestésica reduce el sangrado postoperatorio respecto a administrarlo antes de la liberación del torniquete. Nuestro objetivo secundario era determinar si una segunda dosis reduce significativamente el sangrado. Material y métodos: Ensayo clínico prospectivo con 212 pacientes programados para prótesis total de rodilla, aleatorizados en 4 grupos. El ácido tranexámico se administró antes de la isquemia en los «grupos preinducción» (1 y 2) y justo antes de la liberación del torniquete en los «grupos preliberación» (3 y 4). Los grupos 2 y 4 recibieron una segunda dosis 3h después. La variable principal fue el sangrado postoperatorio (visible y el calculado). Las variables secundarias fueron la variación de hemoglobina, complicaciones y transfusión. Resultados: El sangrado total calculado fue 1563ml (IC 95%: 1445-1681) en los grupos preinducción frente a 1576ml (IC 95%: 1439-1713) en los preliberación (p=0,9); los de dosis única sangraron 1579ml (IC 95%: 1452-1706) frente a 1559ml (IC 95%: 1431-1686) en los de 2 dosis (p=0,82). La hemoglobina al alta fue 10,4 (IC 95%: 10,2-10,7) con una dosis frente a 10,8g/dl (IC 95%: 10,6-11,1) con 2 dosis (p=0,06). Conclusiones: No se detectaron diferencias en sangrado ni transfusión dependiendo del momento de administración del ácido tranexámico. Una segunda dosis tampoco tuvo impacto significativo.(AU)

Background and objectives: The ideal timing of tranexamic acid administration in total knee arthroplasty with tourniquet remains unclear. Our primary objective was to prove if administering it before surgical incision, instead of before releasing the tourniquet, reduces postoperative bleeding. A second objective was to determine whether a second dose reduces post-operative bleeding. Material and methods: A prospective, double-blind clinical trial was performed on 212 patients scheduled for total knee arthroplasty. They were randomised into 4 groups. Tranexamic acid was administered before the surgical incision in “pre-induction groups” (1 and 2), and just before the tourniquet release in “pre-release groups” (3 and 4). Groups 2 and 4 received a second dose 3hours post-surgery. Main outcome was postoperative bleeding (visible blood loss and calculated total bleeding). Secondary outcomes were haemoglobin variations, complications and transfusion rate. Results: The mean calculated total bleeding was 1563ml (95%CI: 1445 to 1681) in preinduction groups versus 1576ml (95%CI: 1439 to 1713) in pre-release groups (P=.9); 1579ml (95%CI: 1452 to 1706) in single-dose groups versus 1559ml (95%CI: 1431 to 1686) in double-dose groups (P=.82). One patient was transfused. The mean haemoglobin at discharge was 10.4g/dl (95%CI: 10.2 to 10.7) in singledose groups versus 10.8 (95%CI: 10.6 to 11.1) in double-dose groups (P=.06). Conclusions: There were no differences in bleeding or transfusion regarding the time of tranexamic acid administration. The second dose had not impact on outcomes.(AU)

Clinical trial to determine whether the timing of tranexamic acid administration influences perioperative bleeding in total knee arthroplasty.

BACKGROUND AND OBJECTIVES: The ideal timing of tranexamic acid administration in total knee arthroplasty with tourniquet remains unclear. Our primary objective was to prove if administering it before surgical incision, instead of before releasing the tourniquet, reduces postoperative bleeding. A second objective was to determine whether a second dose reduces post-operative bleeding. MATERIAL AND METHODS: A prospective, double-blind clinical trial was performed on 212 patients scheduled for total knee arthroplasty. They were randomised into 4 groups. Tranexamic acid was administered before the surgical incision in "pre-induction groups" (1 and 2), and just before the tourniquet release in "pre-release groups" (3 and 4). Groups 2 and 4 received a second dose 3h post-surgery. Main outcome was postoperative bleeding (visible blood loss and calculated total bleeding). Secondary outcomes were haemoglobin variations, complications and transfusion rate. RESULTS: The mean calculated total bleeding was 1563ml (95%CI: 1445-1681) in preinduction groups versus 1576ml (95%CI: 1439-1713) in pre-release groups (P=0.9); 1579ml (95%CI: 1452-1706) in single-dose groups versus 1559ml (95%CI: 1431-1686) in double-dose groups (P=0.82). One patient was transfused. The mean haemoglobin at discharge was 10.4g/dl (95%CI: 10.2-10.7) in singledose groups versus 10.8 (95%CI: 10.6-11.1) in double-dose groups (P=0.06). CONCLUSIONS: There were no differences in bleeding or transfusion regarding the time of tranexamic acid administration. The second dose had not impact on outcomes. TRIAL REGISTRATION: EudraCT 2016-000071-24.