Prevention of Thromboembolism Using Apixaban vs Enoxaparin Following Spinal Cord Injury

• Status: Not yet recruiting
• Trial end date: 2025-02-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Loewenstein Hospital
• Treatments: Apixaban; Enoxaparin; Enoxaparin sodium

Criteria

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