Prevention of Thromboembolism Using Apixaban vs Enoxaparin Following Spinal Cord Injury

Recruiting now · Not applicable

Conditions studied: Spinal Cord Injuries, Spinal Diseases

In brief

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.

Key facts

Study ID

NCT05484557

Run by

Loewenstein Hospital

People needed

60

Starts

2023-09-06

Expected to finish

2026-02-01

Last updated by the study team

2025-05-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• spinal cord injury (traumatic of not traumatic), Hebrew speaker.

You may not qualify if…

• 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

Where it is running

• Loewenstein Rehabilitation Hospital — Raanana, Israel (enrolling)

Full record on ClinicalTrials.gov

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