The incidence of venous thromboembolic events in trauma patients after tranexamic acid administration: an EAST multicenter study

To determine if there is a significant association between administration of tranexamic acid (TXA) in severely bleeding, injured patients, and venous thromboembolism (VTE), myocardial infarction (MI), or cerebrovascular accident (CVA). A multicenter, retrospective study was performed. Inclusion criteria were: age 18-80 years old and need for 5 units or more of blood in the first 24 h after injury. Exclusion criteria included: death within 24 h, pregnancy, administration of TXA more than 3 h following injury, and routine ultrasound surveillance for deep venous thrombosis. Incidence of VTE was the primary outcome. Secondary outcomes included MI, CVA, and death. A power analysis found that a total of 830 patients were needed to detect a true difference in VTE risk. 1333 patients (TXA = 887, No-TXA = 446 patients) from 17 centers were enrolled. There were no differences in age, shock index, Glasgow coma score, pelvis/extremity abbreviated injury score, or paralysis. Injury severity score was higher in the No-TXA group. Incidence of VTE, MI, or CVA was similar between the groups. The TXA group required significantly less transfusion (P \u3c 0.001 for all products) and had a lower mortality [adjusted odds ratio 0.67 (95% confidence interval 0.45-0.98)]. Despite having a higher extremity/pelvis abbreviated injury score, results did not change when evaluating only patients with blunt injury. Use of TXA in bleeding, injured patients is not associated with VTE, MI, or CVA but is associated with a lower transfusion need and mortality

The incidence of venous thromboembolic events in trauma patients after tranexamic acid administration: an EAST multicenter study.

To determine if there is a significant association between administration of tranexamic acid (TXA) in severely bleeding, injured patients, and venous thromboembolism (VTE), myocardial infarction (MI), or cerebrovascular accident (CVA). A multicenter, retrospective study was performed. Inclusion criteria were: age 18-80 years old and need for 5 units or more of blood in the first 24 h after injury. Exclusion criteria included: death within 24 h, pregnancy, administration of TXA more than 3 h following injury, and routine ultrasound surveillance for deep venous thrombosis. Incidence of VTE was the primary outcome. Secondary outcomes included MI, CVA, and death. A power analysis found that a total of 830 patients were needed to detect a true difference in VTE risk. 1333 patients (TXA = 887, No-TXA = 446 patients) from 17 centers were enrolled. There were no differences in age, shock index, Glasgow coma score, pelvis/extremity abbreviated injury score, or paralysis. Injury severity score was higher in the No-TXA group. Incidence of VTE, MI, or CVA was similar between the groups. The TXA group required significantly less transfusion (P \u3c 0.001 for all products) and had a lower mortality [adjusted odds ratio 0.67 (95% confidence interval 0.45-0.98)]. Despite having a higher extremity/pelvis abbreviated injury score, results did not change when evaluating only patients with blunt injury. Use of TXA in bleeding, injured patients is not associated with VTE, MI, or CVA but is associated with a lower transfusion need and mortality

PREVENTion of CLots in Orthopaedic Trauma (PREVENT CLOT): a randomised pragmatic trial protocol comparing aspirin versus low-molecular-weight heparin for blood clot prevention in orthopaedic trauma patients

Introduction Patients who sustain orthopaedic trauma are at an increased risk of venous thromboembolism (VTE), including fatal pulmonary embolism (PE). Current guidelines recommend low-molecular-weight heparin (LMWH) for VTE prophylaxis in orthopaedic trauma patients. However, emerging literature in total joint arthroplasty patients suggests the potential clinical benefits of VTE prophylaxis with aspirin. The primary aim of this trial is to compare aspirin with LMWH as a thromboprophylaxis in fracture patients.Methods and analysis PREVENT CLOT is a multicentre, randomised, pragmatic trial that aims to enrol 12 200 adult patients admitted to 1 of 21 participating centres with an operative extremity fracture, or any pelvis or acetabular fracture. The primary outcome is all-cause mortality. We will evaluate non-inferiority by testing whether the intention-to-treat difference in the probability of dying within 90 days of randomisation between aspirin and LMWH is less than our non-inferiority margin of 0.75%. Secondary efficacy outcomes include cause-specific mortality, non-fatal PE and deep vein thrombosis. Safety outcomes include bleeding complications, wound complications and deep surgical site infections.Ethics and dissemination The PREVENT CLOT trial has been approved by the ethics board at the coordinating centre (Johns Hopkins Bloomberg School of Public Health) and all participating sites. Recruitment began in April 2017 and will continue through 2021. As both study medications are currently in clinical use for VTE prophylaxis for orthopaedic trauma patients, the findings of this trial can be easily adopted into clinical practice. The results of this large, patient-centred pragmatic trial will help guide treatment choices to prevent VTE in fracture patients.Trial registration number NCT02984384