Actively Recruiting
Prevention of Thromboembolism Using Apixaban vs Enoxaparin Following Spinal Cord Injury
Led by Loewenstein Hospital · Updated on 2025-05-09
60
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
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 study's duration, which started in September 2023 and is expected to end by February 2026.
CONDITIONS
Brief Title
Prevention of Thromboembolism Using Apixaban vs Enoxaparin Following Spinal Cord Injury
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Spinal cord injury (traumatic or non-traumatic)
- Hebrew speaker
You will not qualify if you...
- Contraindication for anticoagulant treatment
- Receiving any other anticoagulant treatment
- Need for anticoagulant treatment for reasons other than VTE prevention after spinal cord injury
- Active significant bleeding
- Any lesion or condition with high risk for major bleeding
- Hepatic disease with coagulopathy and bleeding risk
- Pregnancy or breast-feeding
- Heart valve-related issues
- Galactose intolerance
- Active cancer
- Need for thrombolysis or pulmonary embolectomy
- Renal impairment
- Sensitivity to medication excipients
- Anti-phospholipid syndrome
- Prosthetic heart valve
- Acute ischemic stroke
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 to 12 weeks
Participants receive treatment with either Apixaban or Enoxaparin to prevent thromboembolism following spinal cord injury.
Weekly visits for up to 12 weeks
Trial Site Locations
Total: 1 location
1
Loewenstein Rehabilitation Hospital
Raanana, Israel
Actively Recruiting
Research Team
A
Amiram Catz, MD PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here