Comparing Rivaroxaban and Low-Molecular Weight Heparin to Prevent Blood Clots in Adults With Lower Limb Trauma Requiring Brace or Cast

What this Trial Is About

Lower limb trauma that requires immobilization is common and raises the risk of venous thromboembolism VTE. The TRiPcast score helps identify patients at high risk score 7 who need preventive anticoagulant treatment. While low molecular weight heparins LMWH are standard, recent studies suggest they may not fully prevent VTE in high-risk patients. This trial compares rivaroxaban, a direct oral anticoagulant, with LMWH to assess which is more effective and easier to use for preventing blood clots in these patients. Participants with lower limb trauma and a TRiPcast score of 7 or higher are randomly assigned to receive either rivaroxaban 10 mg orally once daily or LMWH injections during the period of immobilization, until they can bear weight on the limb again. Treatment begins in the emergency department and continues at home, with dosing for LMWH following local guidelines and rivaroxaban fixed at 10 mg daily. Throughout the study, participants are monitored at 45 and 90 days after treatment start to track symptomatic blood clots and bleeding events. Their satisfaction with the treatment is also assessed. Researchers measure the rate of symptomatic venous thromboembolic events primarily at 45 days and evaluate safety, treatment satisfaction, and cost-effectiveness at 90 days. The total follow-up lasts up to 90 days to fully capture outcomes and treatment impact.

RIVAroxaban Versus Low-molecular Weight Heparin in Patients With Lower Limb Trauma Requiring Brace or CASTing