Prevention of Thromboembolism Using Apixaban vs Enoxaparin Following Spinal Cord Injury

Study Overview
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Brief Summary
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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 end of the treatment. Bleeding events will be recorded and hematocrit will be monitored every two weeks.

Official Title
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Prevention of Thromboembolism Using Apixaban vs Enoxaparin Following Spinal Cord Injury

Conditions
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Spinal Cord Injuries, Spinal Diseases

Intervention / Treatment
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* Drug: Apixaban
* Drug: Enoxaparin Sodium


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: spinal cord injury (traumatic of not traumatic), Hebrew speaker. Exclusion Criteria: contra-indication for anticoagulant treatment concomitant treatment with any other anticoagulant anticoagulant treatment needed for indications other than VTE prevention following spinal cord injury active clinically significant bleeding any lesion or condition considered a significant risk factor for major bleeding. hepatic disease associated with coagulopathy and clinically relevant bleeding risk pregnancy or breast-feeding heart valve related issues galactose intolerance active cancer patients who require thrombolysis or pulmonary embolectomy patients with renal impairment sensitivity to excipients of the medication anti phospholipid syndrome prosthetic heart valve acute ischemic stroke

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: study<br>treatment with Apixaban | Drug: Apixaban<br>* treatment for 6 to 12 weeks<br>|
| Active Comparator: Control<br>treatment with Enoxaparin | Drug: Enoxaparin Sodium<br>* treatment for 6 to 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with venous thromboembolism (VTE) | deep vein thrombosis or pulmonary embolism | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with bleeding events. | bleeding occurrence (decrease of hemoglobin by at least 1 g/dL) during the medication period. | 6 to 12 weeks |