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
125 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Prevention of Thromboembolism Using Apixaban vs Enoxaparin Following Spinal Cord Injury
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have a spinal cord injury (traumatic or non-traumatic)
- Must be a Hebrew speaker
You will not qualify if you...
- Contraindication for anticoagulant treatment
- Receiving any other anticoagulant treatment
- Need anticoagulant treatment for reasons other than VTE prevention after spinal cord injury
- Active clinically significant bleeding
- Any lesion or condition that is a significant risk factor for major bleeding
- Liver disease with coagulopathy and bleeding risk
- Pregnancy or breastfeeding
- Heart valve problems
- Galactose intolerance
- Active cancer
- Need for thrombolysis or pulmonary embolectomy
- Kidney problems
- Sensitivity to medication ingredients
- Antiphospholipid syndrome
- Prosthetic heart valve
- Acute ischemic stroke
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Loewenstein Rehabilitation Hospital
Raanana, Israel
Actively Recruiting
Research Team
A
Amiram Catz, MD PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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