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Prevention of Thromboembolism Using Apixaban vs Enoxaparin Following Spinal Cord Injury

Prevention of Thromboembolism Using Apixaban vs Enoxaparin Following Spinal Cord Injury

Recruiting
18 years and older
All
Phase N/A

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Overview

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.

Eligibility

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

Study details
    Spinal Cord Injuries
    Spinal Diseases

NCT05484557

Loewenstein Hospital

22 May 2025

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