The advantages of using tranexamic acid in anterior cruciate ligament reconstruction: a randomized controlled trial.

OBJECTIVE: The number of participants in sports or some form of recreation globally has led to an increase in the incidence of anterior cruciate ligament (ACL) injuries and the number of surgeries performed. Although it does not belong to risky surgical interventions, this operation is accompanied by complications that slow down post-operative rehabilitation. The objective is to analyze the effects of intra-articular (IA) injection of tranexamic acid (TXA) on the reduction of post-operative drained blood volume, pain intensity, and incidence of hemarthrosis after ACL reconstruction. METHODS: This prospective research included 124 patients undergoing ACL reconstruction surgery, randomly divided into two groups. The TXA group received IA TXA, whereas an equal amount of placebo was administered using the same route in the control group. RESULTS: The research has shown that IA injection of TXA effectively reduces post-operative blood loss (TXA group 71.29 ± 40.76 vs. control group 154.35 ± 81.45), reducing the intensity of post-operative pain (p < 0.001) and the incidence of hemarthrosis. CONCLUSION: The application of TXA significantly reduced post-operative bleeding and pain intensity, which accelerated the post-operative period.

OBJETIVO: El mayor número de participantes en deportes o alguna forma de recreación en todo el mundo ha llevado a un aumento en la incidencia de lesiones del ligamento cruzado anterior (LCA) y de las cirugías realizadas. Aunque no es una intervención quirúrgica de riesgo, esta operación va acompañada de complicaciones que ralentizan la rehabilitación posoperatoria. El objetivo es analizar los efectos de la inyección intraarticular de ácido tranexámico (TXA) sobre la reducción del volumen sanguíneo drenado posoperatorio, la intensidad del dolor y la incidencia de hemartrosis tras la reconstrucción del LCA. MÉTODO: Esta investigación prospectiva incluyó 124 pacientes sometidos a cirugía de reconstrucción del LCA, divididos aleatoriamente en dos grupos: uno recibió TXA intraarticular y otro (grupo de control) una cantidad igual de placebo por la misma vía. RESULTADOS: La investigación ha demostrado que la inyección intraarticular de TXA reduce efectivamente la pérdida de sangre posoperatoria (grupo TXA 71.29 ± 40.76 vs. grupo control 154.35 ± 81.45), reduciendo la intensidad del dolor posoperatorio (p < 0.001) y la incidencia de hemartrosis. CONCLUSIONES: La aplicación de TXA redujo significativamente el sangrado posoperatorio y la intensidad del dolor, lo que aceleró el posoperatorio.

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.

Efficacy and safety of topical application of tranexamic acid in patients undergoing reconstructive plastic surgery after excision of facial skin cancers: a randomised clinical trial / Uso transoperatório tópico do ácido tranexâmico em cirurgia plástica reconstrutora em tumores faciais: Ensaio clínico randomizado

ABSTRACT Introduction: Tranexamic acid (TA) has attracted increased attention among surgical specialties, but its use in plastic surgery is limited. The aim of this study was to assess the efficacy and safety of topical administration of 3% TA solution in reconstructive surgery of the face and scalp after excision of skin cancers. Methods: a randomized, double-blind, parallel-group clinical trial was conducted in patients aged 18 years or older with malignant skin neoplasms in the face or scalp region (ICD-10 C44.9). The primary outcome was volume of blood loss in the intraoperative and immediate postoperative period. Secondary outcomes included difficult-to-control intraoperative haemorrhage, hematoma, ecchymosis, and other adverse events. Results: of the 54 included patients, 26 were randomised to TA group and 28 to placebo group. The mean blood loss was 11.42ml (SD 6.40, range 8.83-14.01) in the TA group, and 17.6ml (SD 6.22, range 15.19-20.01) in the placebo group, representing a mean decrease of 6.18ml (35.11%) (p=0.001). TA significantly reduced the risk of ecchymosis (RR = 0.046; 95% CI: 0.007-0.323). Only two patients in the placebo group experienced ischemia in the flaps, and one patient in the placebo group experienced tissue necrosis requiring surgical reintervention. There were no surgical wound infections, thromboembolic phenomena, or other adverse events related to TA. Conclusions: topical TA may reduce intraoperative and immediate postoperative bleeding, with a significantly decreased risk of ecchymosis. There is no evidence of ischemic damage of flaps, systemic thromboembolic complications, or other adverse events.

RESUMO Introdução: o ácido tranexâmico (AT) ganhou reconhecimento em diversas especialidades cirúrgicas na prevenção sangramentos e complicações associadas, porém seu uso na cirurgia plástica ainda é limitado. O objetivo deste estudo foi avaliar a eficácia e segurança do uso tópico do AT na cirurgia reparadora oncológica da face e escalpo. Metodologia: foi realizado um ensaio clínico randomizado, duplo-cego, em pacientes maiores de 18 anos, portadores de neoplasias malignas de pele na região da cabeça (CID-10 C44.9). Os desfechos avaliados foram volume de perda sanguínea no pós-operatório imediato, hemorragia transoperatória de difícil controle, hematomas, equimoses, isquemia, necrose de tecidos, infecção de ferida operatória, efeitos tromboembólicos e outras intercorrências. Resultados: foram incluídos 54 pacientes, 26 no grupo AT e 28 no grupo placebo. O sangramento médio foi de 11,42ml, DP 6,40 (8,83 a 14,01) no grupo AT e de 17,6ml, DP 6,22 (15,19 a 20,01) no grupo controle, representando uma diminuição média de 6,18ml (35,11%) nas perdas sanguíneas (p=0,001). O AT reduziu significativemente o risco de equimoses (grupo AT: 1/26, 3,9% vs. grupo placebo: 23/28, 82,1%; p=0,000), representando uma redução relativa de 95,4% (RR=0,046; IC de 95%: 0,007-0,323). Houve dois casos de isquemia cutânea e um caso de necrose no grupo placebo, sem outras complicações no grupo AT. Conclusão: o uso tópico do AT foi efetivo na redução do sangramento transoperatório e pós-operatório imediato, com importante diminuição no risco de equimoses, não sendo evidenciados sofrimento isquêmico de retalhos, complicações sistêmicas tromboembólicas ou outros eventos adversos.

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.

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.

El empleo del ácido tranexámico en ortopedia y traumatología / The use of tranexamic acid in orthopedics and traumatology

Introducción: En las dos últimas décadas se han incrementado las publicaciones sobre el empleo del ácido tranexámico en diferentes especialidades quirúrgicas; entre ellas, la cirugía ortopédica y traumatológica. Objetivo: Demostrar la importancia del ácido tranexámico en la cirugía electiva y de urgencia en ortopedia y traumatología. Desarrollo: Se revisaron las bases de datos Pubmed/Medline, SciELO, BVS, Scopus, Ebsco y Cochrane. Se emplearon los descriptores ácido tranexámico, reducción del sangrado posoperatorio en ortopedia, pérdida de sangre, agentes hemostáticos, riesgo de transfusión y manejo del politraumatizado. Fueron incluidos artículos originales de investigación, de revisión, guías terapéuticas, metaanálisis y editoriales. Conclusiones: Aunque algunos autores divergen en cuanto a la dosis adecuada de ácido tranexámico en ortopedia y traumatología, todos concluyen que este producto controla el sangrado en situaciones traumáticas y en cirugías electivas o de urgencia(AU)

Introduction: Currently, publications on the use of tranexamic acid in different surgical specialties have increased; among them, orthopedic and trauma surgery. Objective: To validate the importance of tranexamic acid in elective and emergency surgery in orthopedics and traumatology. Discussion: Pubmed/Medline, SciELO, VHL, Scopus, Ebsco and Cochrane databases were reviewed, using the descriptors tranexamic acid, reduction of postoperative bleeding in orthopedics, blood loss, hemostatic agents, transfusion risk and management of multiple trauma patients. Conclusions: Although some authors diverge regarding the adequate dose of tranexamic acid in orthopedics and traumatology, all conclude that this product controls bleeding in traumatic situations and in elective or emergency surgeries(AU)

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.

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.

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.

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)

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)

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.

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

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.

[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.

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 2 parallel 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 2 groups was 169.2ml; which means a save of 20.4%; 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.

[Translated article] Implementation of a rapid recovery protocol in total knee arthroplasty. A randomised controlled trial.

BACKGROUND: Rapid recovery (RP) in total knee arthroplasty may increase the functionality while reducing costs. The aim of this study is to prove the benefits of a rapid recovery programme compared to our classic protocol. PATIENTS AND METHODS: We performed a RCT (NCT03823573) in patients undergoing otal knee arthroplasty. Intervention group (RP protocol) received local infiltration of levo-bupivacaine in the periarticular tissue and supervized ambulation 4-6h after surgery. Control (C) group received a femoral nerve block with levo-bupivacaine, while a drain was used. Ambulation after its removal. All the patients completed an Oxford Knee Score prior to surgery and 6 months after discharge. An ecodoppler to assess the presence of deep vein thrombosis was made 1 month after discharge. Minimum follow-up was of 6 months. RESULTS: A total of 175 patients were included in the trial (92 patients in the control group, 83 patients in the RP group). There were no differences in sex, age, implanted prosthesis, haemoglobin drop, need for transfusion, range of motion on discharge (C: 82.6°, RP: 85°) and at the end of the follow-up (C: 105.1, RP: 106.6), Oxford knee score improvement (C: 17.5 points; RP: 19.3 points), patient satisfaction or re-admissions at the emergency department (C: 7.6%; RP: 10.8%). Significancy was found on time of ischaemia (C: 81.29min; RP: 85.35min; p=.03), need for morphine shots (C: 19.7%; RP: 38.6%; p=.007), hospital stay (C: 3.84 days; RP: 2.54 days, p<.0001) and time until ambulation (C: 2.46 days; RP: 0.23 days; p<.0001). CONCLUSION: Rapid recovery protocols can reduce hospital stay without increasing complications or need for re-admission.

The Role of Tranexamic Acid in the Prevention and Management of Blood Loss in Total Joint Arthroplasty / O papel do ácido tranexâmico na prevenção e gerenciamento da perda de sangue na artroplastia total de articulação

Abstract Objective To collect data on the role played by tranexamic acid in the prevention and management of blood loss in patients undergoing total hip arthroplasty and total knee arthroplasty. Methods In the present prospective, comparative study, 30 patients undergoing total hip arthroplasty (THA) or total knee arthroplasty (TKA) were randomly allocated into 1 of 2 groups with 15 patients each. Tranexamic acid was administered by intravenous and topical routes in the study group, but it was not administered in the control group. Preoperative blood parameters, intraoperative and postoperative blood loss, and need for blood transfusion were noted. Statistical analysis was performed using the chisquared test and the independent t-test. Results The study group had statistically significant higher postoperative hemoglobin values (p = 0.03), less difference between pre and postoperative hemoglobin value (p = 0.046), less difference between pre and postoperative packed-cell volume (p = 0.06), less intraoperative measured blood loss (p = 0.015), and less volume of blood collected in the drain (p = 0.0291) compared with the control group. There was also reduced frequency of blood transfusions in the study group (p = 0.0008). Conclusion Tranexamic acid is associated with reduced intra and postoperative blood loss and reduced frequency of blood transfusions in patients undergoing THA/TKA.

Resumo Objetivo Coletar dados sobre o papel desempenhado pelo ácido tranexâmico na prevenção e gerenciamento da perda de sangue em pacientes submetidos à artroplastia total do quadril (ATQ) e à artroplastia total do joelho (ATJ). Métodos Neste estudo prospectivo e comparativo, 30 pacientes submetidos à ATQ ou à ATJ foram alocados aleatoriamente em 1 de 2 grupos com 15 pacientes. O ácido tranexâmico foi administrado por rotas intravenosas e tópicas no grupo de intervenção, mas não foi administrado no grupo controle. Foram observados parâmetros sanguíneos pré-operatórios, perda de sangue intrae pós-operatória e necessidade de transfusão de sangue. A análise estatística foi realizada utilizando-se teste do qui-quadrado e o teste-t independente. Resultados O grupo de intervenção apresentou hemoglobina mais elevada no pósoperatório de forma estatisticamente significante (p = 0,03), menor diferença entre concentração de hemoglobina pré- e pós-operatória (p = 0,046), menor diferença entre volume de células embaladas pré- e pós-operatório (p = 0,06), menor perda de sangue intraoperatória medida (p = 0,015) e menor volume de sangue coletado na drenagem (p = 0,0291) em comparação com o grupo controle. Também houve redução da frequência de transfusões de sangue no grupo de intervenção (p = 0,0008). Conclusão O ácido tranexâmico está associado à redução da perda sanguínea intraoperatória e pós-operatória e à redução da frequência de transfusões de sangue em pacientes submetidos à ATQ/ATJ.

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.

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.