Prevention of Thromboembolism Using Apixaban vs Enoxaparin Following Spinal Cord Injury

What this Trial Is About

Researchers are evaluating the prevention of venous thromboembolism VTE in patients with spinal cord injuries SCI during the acute and sub-acute phases. This study compares the use of Apixaban versus Enoxaparin, which is the usual prophylactic anticoagulant treatment. The purpose is to assess which treatment better prevents blood clots in this patient population, with monitoring of clot formation and bleeding risks. The study is sponsored by Loewenstein Hospital and involves randomized assignment to treatment groups without masking. Participants in the sub-acute phase of SCI rehabilitation will receive either Enoxaparin at a dose of 40 mg once daily or Apixaban at doses between 2.5 mg and 5 mg twice daily, determined by the treating physician. Treatment duration depends on injury severity 6 weeks for AIS grades C-D and 12 weeks for AIS grades A-B. The study includes two groups one receiving Apixaban and the other Enoxaparin, both administered as drug treatments during the specified periods. Throughout the study, participants will undergo evaluations every two weeks, including D-Dimer tests to detect blood clots and ultrasound Doppler scans at the beginning and end of treatment to assess VTE presence. Bleeding events will be recorded, and hematocrit levels monitored regularly. The primary outcome is the number of participants who develop VTE over two years, while secondary outcomes focus on bleeding events within 6 to 12 weeks. Participants remain under medical supervision for the studys duration, which started in September 2023 and is expected to end by February 2026.

Prevention of Thromboembolism Using Apixaban vs Enoxaparin Following Spinal Cord Injury