drugset / Trial / NCT05484557

Prevention of Thromboembolism Using Apixaban vs Enoxaparin Following Spinal Cord Injury

NCT05484557

Recruiting 60 enrolled Loewenstein Hospital
RandomizedParallel-groupOpen-labelPrevention

Summary

Currently, Enoxaparin is the usual prophylactic anticoagulant treatment at the acute and sub-acute phases of spinal cord injury (SCI). Patients at the sub-acute phase of SCI (rehabilitation) will be given either Enoxaparin 40 mg/day (control) or Apixaban 2.5-5 mg twice a day. Apixaban dose will be determined by the treating physician. Treatment will be continued for either 6 or 12 weeks following injury (for AIS grades C-D and A-B respectively). Endpoints: Venous thromboembolism will be evaluated by D-Dimer test every 2 weeks and an ultrasound doppler at the beginning and the end of the treatment. Bleeding events will be recorded and hematocrit will be monitored every two weeks.

Timeline

Start
2023-09-06
Primary completion
2025-08
Completion
2026-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Apixaban Small molecule 2.5 mg
Subject Apixaban Small molecule 5 mg
Comparator Enoxaparin sodium Other / unclassified 40 mg

Indications