Prevention of Thromboembolism Using Apixaban vs Enoxaparin Following Spinal Cord Injury

September 6, 2026 updated by: amiram-catz, Loewenstein Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Israel
      • Raanana, Israel
        • Recruiting
        • Loewenstein Rehabilitation Hospital
        • Contact:
          • Sara Lipkin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: study
treatment with Apixaban
Drug: Apixaban
treatment for 6 to 12 weeks
Active Comparator: Control
treatment with Enoxaparin
Drug: Enoxaparin Sodium
treatment for 6 to 12 weeks

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Loewenstein Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 6, 2023

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

February 1, 2028

Study Registration Dates

First Submitted

July 24, 2022

First Submitted That Met QC Criteria

August 1, 2022

First Posted (Actual)

August 2, 2022

Study Record Updates

Last Update Posted (Actual)

September 9, 2026

Last Update Submitted That Met QC Criteria

September 6, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0023-20-LOE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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