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1.
Trials ; 25(1): 623, 2024 Sep 27.
Artigo em Inglês | MEDLINE | ID: mdl-39334224

RESUMO

BACKGROUND: Tranexamic acid (TXA) effectively attenuates hyperfibrinolysis and preemptive administration has been employed to reduce bleeding and blood transfusions in various surgical settings. However, TXA administration could be associated with adverse effects, such as seizures and thromboembolic risks. While patients with fibrinolysis shutdown showed greater thromboembolic complications and mortality, TXA administration may aggravate the degree of shutdown in these patients. Selective TXA administration based on the results of rotational thromboelastometry (ROTEM) would be non-inferior to preemptive TXA administration in reducing postoperative bleeding and beneficial in reducing its risks in patients undergoing cardiovascular surgery. METHODS: This non-inferiority, randomized, double-blind, placebo-controlled, multicenter trial will be performed in 3 tertiary university hospitals from August 2023 to March 2025. Seven hundred sixty-four patients undergoing cardiovascular surgery will be randomly allocated to get TXA as a preemptive (Group-P) or goal-directed strategy (Group-GDT) in each institution (with a 1:1 allocation ratio). After anesthesia induction, TXA (10 mg/kg and 2 mg/kg/h) and a placebo are administered after anesthesia induction in Group-P and Group-GDT, respectively. ROTEM tests are performed immediately before weaning from CPB and at the considerable bleeding post-CPB period. After getting the test results, a placebo is administered in Group-P (regardless of the test results). In Group-GDT, placebo or TXA is administered according to the results: placebo is administered if the amplitude at 10 min (A10-EXTEM) is ≥ 40 mm and lysis within 60 min (LI60-EXTEM) of EXTEM assay is ≥ 85%, or TXA (20 mg/kg) is administered if A10-EXTEM is < 40 mm or LI60-EXTEM is < 85%. The primary outcome is inter-group comparisons of postoperative bleeding (for 24 h). The secondary measures include comparisons of perioperative blood transfusion, coagulation profiles, reoperation, thromboembolic complications, seizures, in-hospital mortality, fibrinolysis phenotypes, and hospital costs. DISCUSSION: The absence of inter-group differences in postoperative bleeding would support the selective strategy's non-inferiority in reducing postoperative bleeding in these patients. The possible reduction in thromboembolic risks, seizures, and fibrinolysis shutdown in Group-GDT would support its superiority in reducing TXA-induced adverse events and the cost of their management. TRIAL REGISTRATION: This trial was registered at ClinicalTrials.gov with the registration number NCT05806346 on March 28, 2023. TRIAL STATUS: recruiting. Issue date: 2023 March 28 (by Tae-Yop Kim, MD, PhD). The trial was registered in the clinical registration on March 28, 2023 (ClinicalTrials.gov, NCT05806346) and revised to the latest version of its protocol (version no. 8, August 26, 2024) approved by the institutional review boards (IRBs) of all 3 university hospitals (Konkuk University Medical Center, 2023-07-005-001, Asan Medical Center, 2023-0248, and Samsung Medical Center, SMC 2023-06-048-002). Its recruitment was started on August 1, 2023, and will be completed on December 31, 2024. Protocol amendment number: 08 (protocol version 08, August 26, 2024). Revision chronology: 2023 March 28:Original. 2023 April 10:Amendment No 01. The primary reason for the amendment is the modification of Arms (adding one arm for sub-group analyses) and Interventions, Outcome Measures, Study Design, Study Description, Study Status, Eligibility, and Study Identification. 2023 May 03:Amendment No 02. The primary reason for the amendment is to modify the Outcome Measures and update the study status. 2023 July 06:Amendment No 03. The primary reason for amendment is to update the chronological study status. 2023 July 07:Amendment No 04. The primary reason for the amendment is the modification of study information (the treatment category was changed to diagnostic, and Phase 4 was changed to not applicable) and a chronological update on the study status. 2023 September 12:Amendment No 06. The primary reason for the amendment is a chronological update in the study status and the inclusion of additional information regarding contacts/locations and oversight. 2023 December 29:Amendment No 07. The primary reason for the amendment is to modify the outcome measures (including detailed information on outcome measures, addition of extra secondary measures, and chronological updates in study status). 2024 August 26:Amendment No 08. The primary reason for the amendment is to add detailed descriptions regarding data handling and the names and roles of the participating institutions and to update the chronological process of the trial.


Assuntos
Antifibrinolíticos , Hemorragia Pós-Operatória , Tromboelastografia , Ácido Tranexâmico , Humanos , Ácido Tranexâmico/administração & dosagem , Ácido Tranexâmico/efeitos adversos , Método Duplo-Cego , Antifibrinolíticos/administração & dosagem , Antifibrinolíticos/efeitos adversos , Hemorragia Pós-Operatória/prevenção & controle , Hemorragia Pós-Operatória/etiologia , Procedimentos Cirúrgicos Cardiovasculares/efeitos adversos , Resultado do Tratamento , Estudos Multicêntricos como Assunto , Estudos de Equivalência como Asunto , Feminino , Masculino
2.
J Int Med Res ; 52(9): 3000605241285661, 2024 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-39340253

RESUMO

OBJECTIVE: To evaluate the safety and efficacy of intravenous tranexamic acid (TXA) administration in anterior cervical discectomy fusion (ACDF) for the treatment of cervical spondylosis in the elderly. METHODS: Data from elderly patients who underwent ACDF between January 2020 and January 2023 were retrospectively reviewed. Patients who received 1 g intravenous TXA administration before skin incision (TXA group) were compared with patients who did not receive TXA (controls). Total and hidden blood loss were calculated, and the following outcomes were recorded: haemoglobin and haematocrit drop, operation time, drainage duration, drain volume, length of hospitalization, coagulation changes, and incidence of complications. RESULTS: A total of 114 patients were included (TXA group, n = 53 and controls, n = 61). Total blood loss, hidden blood loss, and postoperative drainage volume, haemoglobin and haematocrit drop were significantly lower in the TXA group than the control group. There were no significant differences in operation time, intraoperative blood loss, drainage duration, length of hospitalization, or coagulation function between the two groups. The incidence of complications did not differ significantly between the two groups during 3 months of follow-up. CONCLUSIONS: Intravenous TXA is effective in reducing perioperative blood loss in elderly patients undergoing ACDF without changing the coagulation function or increasing the risk of complications.


Assuntos
Perda Sanguínea Cirúrgica , Vértebras Cervicais , Discotomia , Fusão Vertebral , Ácido Tranexâmico , Humanos , Ácido Tranexâmico/uso terapêutico , Ácido Tranexâmico/administração & dosagem , Ácido Tranexâmico/efeitos adversos , Masculino , Feminino , Estudos Retrospectivos , Idoso , Fusão Vertebral/métodos , Fusão Vertebral/efeitos adversos , Discotomia/efeitos adversos , Discotomia/métodos , Vértebras Cervicais/cirurgia , Perda Sanguínea Cirúrgica/prevenção & controle , Antifibrinolíticos/uso terapêutico , Antifibrinolíticos/administração & dosagem , Antifibrinolíticos/efeitos adversos , Resultado do Tratamento , Espondilose/cirurgia , Duração da Cirurgia , Tempo de Internação , Idoso de 80 Anos ou mais , Administração Intravenosa
5.
PLoS One ; 19(9): e0308070, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-39231164

RESUMO

INTRODUCTION: It is unclear how tranexamic acid (TXA) affects blood loss and seizures in meningioma resections. We performed a systematic review and meta-analysis and tried to evaluate the effectiveness and safety of TXA use for patients undergoing meningioma resections. METHODS: Regards to this systematic review and meta-analysis (registered with CRD42023416693), we searched PubMed, Embase (Ovid), EBSCO, and Cochrane central library up to and including Oct 2023. Patients undergoing meningioma resections treated with TXA and placebo or no treatment were eligible for this study. This would allow delineation of the impact of TXA on blood loss, postoperative seizure, and other complication incidences. RESULTS: Four prospective cohort studies with 781 patients (390 patients in the TXA group and 391 patients in the control group) were conducted via a systematic review and meta-analysis. The results suggested that the application of TXA for patients undergoing meningioma resections reduced mean blood loss of 252 mL with 95% confidence interval (CI) -469.26 to -34.67 (P = 0.02) and I2 of 94% but did not increase postoperative seizure (risk ratio: 1.08; 95%CI: 0.54 to 2.15; P = 0.84) and other complication rates. CONCLUSIONS: This systematic review and meta-analysis suggests that the administration of TXA could reduce blood loss in patients undergoing intracerebral meningioma resection. REGISTRY INFORMATION: The systematic review protocol has been registered at PROSPERO (Registration No. CRD42023416693) on April 23, 2023.


Assuntos
Perda Sanguínea Cirúrgica , Meningioma , Convulsões , Ácido Tranexâmico , Humanos , Meningioma/cirurgia , Ácido Tranexâmico/uso terapêutico , Ácido Tranexâmico/efeitos adversos , Convulsões/tratamento farmacológico , Convulsões/prevenção & controle , Perda Sanguínea Cirúrgica/prevenção & controle , Antifibrinolíticos/uso terapêutico , Antifibrinolíticos/efeitos adversos , Neoplasias Meníngeas/cirurgia , Complicações Pós-Operatórias/prevenção & controle , Complicações Pós-Operatórias/etiologia , Resultado do Tratamento
6.
J Orthop Surg Res ; 19(1): 512, 2024 Aug 27.
Artigo em Inglês | MEDLINE | ID: mdl-39192283

RESUMO

BACKGROUND: The administration of tranexamic acid (TXA) during spinal surgery has been shown to reduce blood loss. However, the efficacy and safety of intravenous TXA (ivTXA) and topical TXA (tTXA) are poorly documented. The present meta-analysis aimed to compare the efficacy and safety of ivTXA and tTXA administration in spinal surgery. METHODS: Potentially relevant academic articles were identified from PubMed, Ovid, Cochrane Library, CNKI database, and Wanfang Data from the date of inception until March 1, 2024. Randomized controlled trials (RCTs) and nonrandomized controlled trials (non-RCTs) were included in our meta-analysis if they compared the efficacy and safety of ivTXA versus tTXA administration during spinal surgery. Secondary sources were identified from the references of the included literature. The meta-analysis was performed in accordance with the guidelines of the Cochrane Reviewer's Handbook and the PRISMA statement. Data were summarized using RevMan 5.3 software from Denmark. RESULTS: Four RCTs and one non-RCT met our inclusion criteria. The pooled outcomes demonstrated that ivTXA groups compared with tTXA groups had significantly less amount of total blood loss [weighted mean difference (WMD)=-159.55, 95% CI (-181.91,-137.19), P < 0.00001], hidden blood loss [WMD=-132.27, 95% CI (-159.81, -104.72), P < 0.00001], intraoperative blood loss [WMD=-86.22, 95% CI (-99.13, -73.31), P < 0.00001, I2 = 96%], and more high postoperative hemoglobin level [WMD = 8.96, 95% CI (5.18, 12.75), P < 0.00001, I2 = 29%], and less transfusion rate [risk ratio (RR) = 1.11, 95% CI (0.81,1.52), P = 0.50, I2 = 94%]. The pooled results showed no significant difference in thromboembolic events (deep venous thrombosis and pulmonary embolism) between the two groups. CONCLUSION: Our meta-analysis demonstrated that ivTXA was more effective than tTXA in inducing hemostatic effect during spinal surgery. However, the risk of a thrombotic event was not different between the two administration methods of TXA. More high quality RCTs are needed to further confirm our conclusions.


Assuntos
Administração Intravenosa , Administração Tópica , Antifibrinolíticos , Perda Sanguínea Cirúrgica , Ácido Tranexâmico , Humanos , Administração Intravenosa/efeitos adversos , Antifibrinolíticos/administração & dosagem , Antifibrinolíticos/efeitos adversos , Perda Sanguínea Cirúrgica/prevenção & controle , Perda Sanguínea Cirúrgica/estatística & dados numéricos , Ensaios Clínicos Controlados Aleatórios como Assunto , Coluna Vertebral/cirurgia , Ácido Tranexâmico/administração & dosagem , Ácido Tranexâmico/efeitos adversos , Resultado do Tratamento
7.
Trials ; 25(1): 520, 2024 Aug 02.
Artigo em Inglês | MEDLINE | ID: mdl-39095919

RESUMO

BACKGROUND: Despite an increase in knowledge, blood loss during burn excisional surgery remains a major challenge and is an independent predictor of mortality. During burn surgery, limited measures are available to control the bleeding. Increased fibrinolysis could be one of the contributing factors of blood loss during burn excisional surgery. Tranexamic acid inhibits the fibrinolytic response, and a small body of evidence shows positive effects of tranexamic acid on the volume of blood loss. METHODS: The main objectives of this study are twofold, (1) to investigate whether tranexamic acid reduces blood loss and (2) to investigate the changes in coagulation after burn trauma and during burn excisional surgery. This study is a multicenter double-blind randomized clinical trial in patients scheduled for burn excisional surgery within the Dutch burn centers. All adult patients scheduled for burn surgery with an expected blood loss of ≥ 250 are eligible for inclusion in this study. The study is powered on a blood loss reduction of 25% in the intervention group. In total, 95 subjects will be included. The intervention group will receive 1500 mg tranexamic acid versus placebo in the other group. Primary endpoint is reduction of blood loss. Secondary endpoints include occurrence of fibrinolysis during surgery, graft take of the split skin graft, and differences in coagulation and blood clot formation. DISCUSSION: This protocol of a randomized controlled trial aims to investigate the efficacy of tranexamic acid in reducing blood loss during burn excisional surgery. Furthermore, this study aims to clarify the coagulation status after burn trauma and during the surgical process. TRIAL REGISTRATION: EudraCT: 2020-005405-10; ClinicalTrial.gov: NCT05507983 (retrospectively registered in August 2022, inclusion started in December 2021).


Assuntos
Antifibrinolíticos , Perda Sanguínea Cirúrgica , Queimaduras , Estudos Multicêntricos como Assunto , Ensaios Clínicos Controlados Aleatórios como Assunto , Ácido Tranexâmico , Ácido Tranexâmico/uso terapêutico , Humanos , Método Duplo-Cego , Antifibrinolíticos/uso terapêutico , Antifibrinolíticos/efeitos adversos , Queimaduras/cirurgia , Queimaduras/complicações , Perda Sanguínea Cirúrgica/prevenção & controle , Fibrinólise/efeitos dos fármacos , Resultado do Tratamento , Países Baixos , Adulto , Coagulação Sanguínea/efeitos dos fármacos , Masculino , Feminino
8.
BMC Musculoskelet Disord ; 25(1): 553, 2024 Jul 17.
Artigo em Inglês | MEDLINE | ID: mdl-39020313

RESUMO

BACKGROUND: Tranexamic acid (TXA) is a widely employed intervention in orthopedic surgeries to minimize blood loss and the need for postoperative transfusions. This study focuses on assessing the efficacy and safety of TXA specifically in undernourished older adults undergoing hip fracture procedures. METHODS: A total of 216 patients were classified into two groups based on the Geriatric Nutritional Risk Index: undernourished and normal. In total, 82 patients received intravenous TXA at a dosage of 15 mg/kg before incision, with an additional 1 g administered intravenously over a 3-hour period postoperatively. Postoperative hemoglobin (Hb) drop, blood transfusion rate, and the incidence of deep venous thrombosis (DVT) were assessed in each group according to the presence or absence of TXA. Additionally, demographic factors including age, sex, body mass index, and serum albumin were investigated. RESULTS: 51.9% patients were identified as undernourished, experiencing progressive anemia (Hb: 10.9 ± 1.5 g/dL) and hypoalbuminemia (serum albumin: 31.9 ± 8 g/L). In comparison with the normal group, undernourished individuals were more likely to sustain femoral neck fractures (undernutrition vs. normal: 56.2 vs. 42.3%) and less likely to incur trochanteric fractures (undernutrition vs. normal: 43.8 vs. 57.7%) (P = 0.043). TXA administration significantly reduced the transfusion rate (P = 0.014) and Hb drop (P = 0.001) in the normal nutritional group, while its impact on the undernourished group remained less pronounced. There was no significant association between TXA administration and the rate of DVT complications, irrespective of the nutritional status. CONCLUSIONS: Undernutrition not only diminishes muscle strength and gait function, leading to various types of hip fractures, but it may also hinder the efficacy of TXA in reducing blood transfusion rates and blood loss.


Assuntos
Antifibrinolíticos , Perda Sanguínea Cirúrgica , Transfusão de Sangue , Fraturas do Quadril , Estado Nutricional , Ácido Tranexâmico , Humanos , Ácido Tranexâmico/administração & dosagem , Ácido Tranexâmico/efeitos adversos , Feminino , Masculino , Idoso , Idoso de 80 Anos ou mais , Fraturas do Quadril/cirurgia , Antifibrinolíticos/administração & dosagem , Antifibrinolíticos/uso terapêutico , Antifibrinolíticos/efeitos adversos , Transfusão de Sangue/estatística & dados numéricos , Perda Sanguínea Cirúrgica/prevenção & controle , Resultado do Tratamento , Trombose Venosa/epidemiologia , Trombose Venosa/prevenção & controle , Desnutrição/epidemiologia , Hemoglobinas/análise , Hemoglobinas/metabolismo , Estudos Retrospectivos , Hemorragia Pós-Operatória/epidemiologia , Hemorragia Pós-Operatória/prevenção & controle , Hemorragia Pós-Operatória/etiologia
9.
BMC Musculoskelet Disord ; 25(1): 475, 2024 Jun 18.
Artigo em Inglês | MEDLINE | ID: mdl-38890633

RESUMO

BACKGROUND: Suction drainages are commonly used after total knee arthroplasty (TKA) procedures; however, their use is somewhat controversial. Recently, some reports have claimed that the administration of tranexamic acid (TXA) may prevent postoperative bleeding following TKAs. Although numerous studies have reported regarding different dosages, timings of administration, or drain clamping times for intravenous and intra-articular TXA injections (IA-TXAs), few have examined whether suction drainage is necessary when TXA is administered. In this study, we compared using suction drainage without TXA administration and IA-TXA without suction drainage and aimed to examine the need for suction drainage during IA-TXA. METHODS: This retrospective study was conducted on 217 patients who had received TKA for osteoarthritis; 104 were placed on suction drainage after TKA without TXA (Group A), whereas the remaining 113 received IA-TXA immediately after surgery without suction drainage (Group B). Our clinical evaluation included assessments of the need for transfusion, presence of postoperative complications, incidence of deep vein thrombosis (DVT), and changes in hemoglobin (Hb), hematocrit (Hct), and D-dimer levels. RESULTS: No significant differences were observed in terms of postoperative complications and preoperative Hb, Hct, or D-dimer levels between the two groups. Although the prevalence of DVT was significantly higher in Group B (p < 0.05), all cases were asymptomatic. Hb and Hct levels were significantly lower in Group A than in Group B at 1, 3, 7, and 14 days postoperatively (p < 0.05), although none of the cases required blood transfusions. D-dimer levels were significantly higher in Group A than in Group B at 1 and 3 days postoperatively (p < 0.05). CONCLUSION: Suction drainage might not be necessary when IA-TXA is administered after TKA procedures.


Assuntos
Antifibrinolíticos , Artroplastia do Joelho , Hemorragia Pós-Operatória , Ácido Tranexâmico , Humanos , Ácido Tranexâmico/administração & dosagem , Ácido Tranexâmico/efeitos adversos , Estudos Retrospectivos , Artroplastia do Joelho/efeitos adversos , Artroplastia do Joelho/métodos , Feminino , Masculino , Idoso , Sucção , Injeções Intra-Articulares , Antifibrinolíticos/administração & dosagem , Antifibrinolíticos/efeitos adversos , Pessoa de Meia-Idade , Hemorragia Pós-Operatória/prevenção & controle , Hemorragia Pós-Operatória/etiologia , Hemorragia Pós-Operatória/epidemiologia , Idoso de 80 Anos ou mais , Osteoartrite do Joelho/cirurgia , Trombose Venosa/prevenção & controle , Trombose Venosa/etiologia , Trombose Venosa/epidemiologia , Resultado do Tratamento
10.
J Neurosurg ; 141(4): 945-954, 2024 Oct 01.
Artigo em Inglês | MEDLINE | ID: mdl-38579356

RESUMO

OBJECTIVE: Chronic subdural hematoma (CSDH) is a prevalent neurosurgical condition, particularly among the elderly. Various treatment options exist, but recurrence rates remain high. This systematic review and meta-analysis aims to assess the efficacy and safety of tranexamic acid (TXA) in the management of CSDH. METHODS: The authors conducted a comprehensive literature search adhering to the 2020 PRISMA guidelines, involving three primary databases (Scopus, PubMed, and Web of Science) that were searched for articles compiled from inception until October 20, 2023. The primary outcome was recurrence of CSDH, and secondary outcomes included complications and SDH volume following TXA treatment. The mean difference and odds ratios with 95% confidence intervals were calculated using the random-effects model. RESULTS: A total of 5 studies, involving 643 patients in the TXA group and 736 patients in the non-TXA group, met the inclusion criteria. The meta-analysis revealed that TXA use led to a significantly lower CSDH recurrence (OR 0.35, 95% CI 0.23-0.53; p < 0.01) without increasing complications (OR 1.84, 95% CI 0.43-7.95; p = 0.42). Additionally, TXA users had a significantly lower CSDH volume compared to the non-TXA group at 3-month follow-up (mean difference -4.56, 95% CI -8.76 to -0.36; p = 0.03). CONCLUSIONS: The findings suggest that TXA might be a promising agent for reducing the risk of CSDH recurrence without elevating the risk of complications. However, these results should be interpreted cautiously due to the limited number of studies included and the methodological heterogeneity. Further large-scale randomized controlled trials are needed to confirm these findings.


Assuntos
Antifibrinolíticos , Hematoma Subdural Crônico , Ácido Tranexâmico , Humanos , Ácido Tranexâmico/uso terapêutico , Ácido Tranexâmico/efeitos adversos , Hematoma Subdural Crônico/tratamento farmacológico , Antifibrinolíticos/uso terapêutico , Antifibrinolíticos/efeitos adversos , Resultado do Tratamento , Recidiva
11.
J Cosmet Dermatol ; 23(6): 2049-2057, 2024 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-38456556

RESUMO

BACKGROUND: There is no standardized and effective treatment modality for Riehl's melanosis. AIMS: To compare the efficacy and safety of oral tranexamic acid (TXA) combined with intense pulsed light (IPL) versus TXA alone in the treatment of refractory Riehl's melanosis. METHODS: A prospective study of 28 subjects with refractory Riehl's melanosis and Fitzpatrick Skin Types III or IV was conducted. All subjects received oral TXA 500 mg daily and 11 of them were treated in combination with monthly IPL therapy for 6 months. The primary outcome measure was mean melanin index (MI), erythema index (EI) and acquired dermal macular hyperpigmentation area and severity index (DPASI). The Physician Global Assessment (PGA) and patient satisfaction scale were documented. RESULTS: After treatment, DPASI, mean MI, and EI were significantly reduced in both groups. The group treated with combination therapy showed better improvement according to MI (p = 0.0032) and DPASI (p = 0.00468). PGA and patient satisfaction scale showed superior efficacy in the combination group. No significant difference was observed in treatment-related side effects. CONCLUSION: The combination of oral TXA and IPL proves to be a safe and satisfactory treatment strategy for refractory Riehl's melanosis.


Assuntos
Antifibrinolíticos , Terapia de Luz Pulsada Intensa , Melanose , Satisfação do Paciente , Ácido Tranexâmico , Humanos , Ácido Tranexâmico/administração & dosagem , Ácido Tranexâmico/efeitos adversos , Melanose/terapia , Melanose/tratamento farmacológico , Melanose/diagnóstico , Estudos Prospectivos , Feminino , Masculino , Pessoa de Meia-Idade , Adulto , Administração Oral , Resultado do Tratamento , Terapia Combinada/efeitos adversos , Terapia Combinada/métodos , Terapia de Luz Pulsada Intensa/efeitos adversos , Terapia de Luz Pulsada Intensa/métodos , Antifibrinolíticos/administração & dosagem , Antifibrinolíticos/efeitos adversos , Índice de Gravidade de Doença
12.
Transfusion ; 64 Suppl 2: S11-S13, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-38461482

RESUMO

Tranexamic acid (TXA) has proven mortality benefit if used early after traumatic injury, likely related to a combination of bleeding reduction and other non-bleeding effects. If TXA is given more than 3 h after traumatic injury, there is a significant and paradoxical increased risk of death due to bleeding. TXA has level 1 evidence for use as a bleeding reduction agent in isolated orthopedic operations, but in polytrauma patients undergoing orthopedic operations, it is not clear if and when TXA is safe or effective once outside the 3-h window of proven trauma efficacy.


Assuntos
Antifibrinolíticos , Hemorragia , Ácido Tranexâmico , Ferimentos e Lesões , Ácido Tranexâmico/uso terapêutico , Humanos , Ferimentos e Lesões/complicações , Ferimentos e Lesões/tratamento farmacológico , Antifibrinolíticos/uso terapêutico , Antifibrinolíticos/efeitos adversos , Hemorragia/tratamento farmacológico , Fatores de Tempo , Traumatismo Múltiplo
13.
Orthopedics ; 47(4): 211-216, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38466825

RESUMO

BACKGROUND: The continuation of long-term warfarin therapy is gaining acceptance in minor surgeries but maintaining therapeutic international normalized ratio (INR) values among patients during major orthopedic procedures raises concern. While bridging therapy with low-molecular-weight heparin is currently recommended for patients receiving anticoagulation, few studies have evaluated the safety of continuing warfarin during total joint arthroplasty. This study evaluated the safety and efficacy of continuous warfarin anticoagulation through total joint arthroplasty with and without prophylactic tranexamic acid (TXA). MATERIALS AND METHODS: We conducted a retrospective, matched-pair analysis of two experimental groups of patients who underwent primary total hip arthroplasty or total knee arthroplasty performed by a single surgeon. Our first experimental group, warfarin plus TXA (warfarin+TXA), consisted of 21 patients who underwent arthroplasty while receiving therapeutic anticoagulation with warfarin (INR, 2.0-3.0) and who received prophylactic TXA. Our second experimental group, warfarin without TXA (warfarin-TXA), consisted of 40 patients who underwent arthroplasty while receiving therapeutic anticoagulation with warfarin (INR, 2.0-3.0) without prophylactic TXA. RESULTS: The percent change in hemoglobin value after surgery, red blood cells transfused, surgical site infections, bleeding complications, and thrombotic complications were similar between both experimental and control groups. When comparing the historical group with the warfarin+TXA group, the addition of TXA resulted in a statistical decrease in mean red blood cells transfused and estimated blood loss, with no statistically significant increase in complications. CONCLUSION: Many factors must be considered when choosing perioperative thromboembolic prophylaxis for arthroplasty candidates with medical comorbidities requiring long-term anticoagulation. This study presents data indicating that it could be safe and effective to continue therapeutic warfarin while using prophylactic TXA. [Orthopedics. 2024;47(4):211-216.].


Assuntos
Anticoagulantes , Antifibrinolíticos , Artroplastia de Quadril , Artroplastia do Joelho , Ácido Tranexâmico , Varfarina , Humanos , Varfarina/uso terapêutico , Varfarina/administração & dosagem , Varfarina/efeitos adversos , Ácido Tranexâmico/administração & dosagem , Ácido Tranexâmico/efeitos adversos , Ácido Tranexâmico/uso terapêutico , Feminino , Anticoagulantes/administração & dosagem , Anticoagulantes/uso terapêutico , Anticoagulantes/efeitos adversos , Masculino , Estudos Retrospectivos , Idoso , Artroplastia de Quadril/efeitos adversos , Antifibrinolíticos/administração & dosagem , Antifibrinolíticos/uso terapêutico , Antifibrinolíticos/efeitos adversos , Artroplastia do Joelho/efeitos adversos , Pessoa de Meia-Idade , Coeficiente Internacional Normatizado
14.
J Neurosurg Spine ; 40(6): 684-691, 2024 Jun 01.
Artigo em Inglês | MEDLINE | ID: mdl-38457792

RESUMO

OBJECTIVE: Complex spinal deformity surgeries may involve significant blood loss. The use of antifibrinolytic agents such as tranexamic acid (TXA) has been proven to reduce perioperative blood loss. However, for patients with a history of thromboembolic events, there is concern of increased risk when TXA is used during these surgeries. This study aimed to assess whether TXA use in patients undergoing complex spinal deformity correction surgeries increases the risk of thromboembolic complications based on preexisting thromboembolic risk factors. METHODS: Data were analyzed for adult patients who received TXA during surgical correction for spinal deformity at 21 North American centers between August 2018 and October 2022. Patients with preexisting thromboembolic events and other risk factors (history of deep venous thrombosis [DVT], pulmonary embolism [PE], myocardial infarction [MI], stroke, peripheral vascular disease, or cancer) were identified. Thromboembolic complication rates were assessed during the postoperative 90 days. Univariate and multivariate analyses were performed to assess thromboembolic outcomes in high-risk and low-risk patients who received intravenous TXA. RESULTS: Among 411 consecutive patients who underwent complex spinal deformity surgery and received TXA intraoperatively, 130 (31.6%) were considered high-risk patients. There was no significant difference in thromboembolic complications between patients with and those without preexisting thromboembolic risk factors in univariate analysis (high-risk group vs low-risk group: 8.5% vs 2.8%, p = 0.45). Specifically, there were no significant differences between groups regarding the 90-day postoperative rates of DVT (high-risk group vs low-risk group: 1.5% vs 1.4%, p = 0.98), PE (2.3% vs 1.8%, p = 0.71), acute MI (1.5% vs 0%, p = 0.19), or stroke (0.8% vs 1.1%, p > 0.99). On multivariate analysis, high-risk status was not a significant independent predictor for any of the thromboembolic complications. CONCLUSIONS: Administration of intravenous TXA during the correction procedure did not change rates of thromboembolic events, acute MI, or stroke in this cohort of adult spinal deformity surgery patients.


Assuntos
Antifibrinolíticos , Complicações Pós-Operatórias , Tromboembolia , Ácido Tranexâmico , Humanos , Feminino , Masculino , Ácido Tranexâmico/uso terapêutico , Ácido Tranexâmico/efeitos adversos , Pessoa de Meia-Idade , Antifibrinolíticos/uso terapêutico , Antifibrinolíticos/efeitos adversos , Tromboembolia/prevenção & controle , Tromboembolia/etiologia , Complicações Pós-Operatórias/epidemiologia , Fatores de Risco , Idoso , Adulto , Perda Sanguínea Cirúrgica/prevenção & controle , Estudos Retrospectivos , Curvaturas da Coluna Vertebral/cirurgia
15.
J Clin Anesth ; 94: 111417, 2024 06.
Artigo em Inglês | MEDLINE | ID: mdl-38387241

RESUMO

STUDY OBJECTIVE: To assess how kidney disease is handled in randomized trials evaluating the safety and efficacy of perioperative tranexamic acid, and to evaluate its effects across levels of kidney function. DESIGN: Systematic review and meta-analysis of randomized controlled trials. SETTING: We screened studies from a previous comprehensive systematic review, and updated its search of PubMed, Embase, and Cochrane CENTRAL to July 31, 2023. PATIENTS: Patients undergoing non-obstetric surgery. INTERVENTIONS: Intravenous tranexamic acid compared to placebo or usual care without tranexamic acid. MEASUREMENT: We summarized the handling of kidney disease in eligibility criteria, dose adjustments for kidney function, and effects of tranexamic acid on thrombotic events, seizures, and bleeding by subgroups of kidney function. MAIN RESULTS: We evaluated 300 trials with 53,085 participants; 45,958 participants (86.6%) were enrolled in 228 trials (76.0%) that explicitly excluded patients with kidney disease. Definitions of kidney diseased used for exclusion varied widely. Most were non-specific and some corresponded to mild disease. Only 5 trials adjusted dosing for kidney function. Meta-analysis of two large trials found tranexamic acid unlikely to substantially increase or decrease the occurrence of thrombotic events in patients with eGFR <60 mL/min/1.73m2 (RR, 0.95; 95% CI: 0.83 to 1.07) or ≥ 60 mL/min/1.73m2 (RR, 1.00; 95% CI, 0.91 to 1.11; P for subgroup difference = 0.47), but both trials excluded patients with severe kidney disease. No analysis could be performed regarding seizure risk. One large trial in noncardiac surgery reported similar reduction in bleeding across subgroups of kidney function but excluded patients with creatinine clearance <30 mL/min. CONCLUSIONS: The large evidence base supporting perioperative tranexamic acid suffers from broad and unjustified exclusion of patients with kidney disease. Typical perioperative dosing of tranexamic acid is likely safe and effective in patients with creatinine clearance >30 mL/min, but effects in more severe kidney disease are unknown.


Assuntos
Antifibrinolíticos , Nefropatias , Ácido Tranexâmico , Humanos , Antifibrinolíticos/efeitos adversos , Creatinina , Hemorragia/prevenção & controle , Ácido Tranexâmico/efeitos adversos
18.
Anesth Analg ; 139(3): 598-608, 2024 Sep 01.
Artigo em Inglês | MEDLINE | ID: mdl-38236761

RESUMO

BACKGROUND: Current clinical guidelines recommend antifibrinolytic treatment for liver transplantation to reduce blood loss and transfusion utilization. However, the clinical relevance of fibrinolysis during liver transplantation is questionable, a benefit of tranexamic acid (TXA) in this context is not supported by sufficient evidence, and adverse effects are also conceivable. Therefore, we tested the hypothesis that use of TXA is associated with reduced blood loss. METHODS: We performed a retrospective cohort study on patients who underwent liver transplantation between 2004 and 2017 at Heidelberg University Hospital, Heidelberg, Germany. Univariable and multivariable linear regression analyses were used to determine the association between TXA administration and the primary end point intraoperative blood loss and the secondary end point intra- and postoperative red blood cell (RBC) transfusions. For further secondary outcome analyses, the time to the first occurrence of a composite end point of hepatic artery thrombosis, portal vein thrombosis, and thrombosis of the inferior vena cava were analyzed using a univariable and multivariable Cox proportional hazards model. RESULTS: Data from 779 transplantations were included in the final analysis. The median intraoperative blood loss was 3000 mL (1600-5500 mL). Intraoperative TXA administration occurred in 262 patients (33.6%) with an average dose of 1.4 ± 0.7 g and was not associated with intraoperative blood loss (regression coefficient B, -0.020 [-0.051 to 0.012], P = .226) or any of the secondary end points (intraoperative RBC transfusion; regression coefficient B, 0.023 [-0.006 to 0.053], P = .116), postoperative RBC transfusion (regression coefficient B, 0.007 [-0.032 to 0.046], P = .717), and occurrence of thrombosis (hazard ratio [HR], 1.110 [0.903-1.365], P = .321). CONCLUSIONS: Our data do not support the use of TXA during liver transplantation. Physicians should exercise caution and consider individual factors when deciding whether or not to administer TXA.


Assuntos
Antifibrinolíticos , Perda Sanguínea Cirúrgica , Transfusão de Eritrócitos , Transplante de Fígado , Ácido Tranexâmico , Humanos , Ácido Tranexâmico/administração & dosagem , Ácido Tranexâmico/efeitos adversos , Feminino , Masculino , Estudos Retrospectivos , Pessoa de Meia-Idade , Antifibrinolíticos/administração & dosagem , Antifibrinolíticos/efeitos adversos , Antifibrinolíticos/uso terapêutico , Perda Sanguínea Cirúrgica/prevenção & controle , Idoso , Resultado do Tratamento , Adulto , Fatores de Risco
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