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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 beginning and the end of the treatment. Bleeding events will be recorded and hematocrit will be monitored every two weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| study | Experimental | treatment with Apixaban |
|
| Control | Active Comparator | treatment with Enoxaparin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apixaban | Drug | treatment for 6 to 12 weeks |
| |
| Enoxaparin Sodium |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with venous thromboembolism (VTE) | deep vein thrombosis or pulmonary embolism | 2 years |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amiram Catz, MD PhD | Contact | 972-9-770-9934 | amiramc@clalit.org.il |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loewenstein Rehabilitation Hospital | Recruiting | Raanana | Israel |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D013122 | Spinal Diseases |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| ID | Term |
|---|---|
| C522181 | apixaban |
| C000711671 | enoxaparin sodium |
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| Drug |
treatment for 6 to 12 weeks |
|
| D014947 | Wounds and Injuries |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |