Prevention of thromboembolism using apixaban vs enoxaparin following spinal cord injury

NCT ID NCT05484557

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By invitation only
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Running, but no longer taking on new participants.
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The trial has finished. Results may not be published yet.
Stopped early
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Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
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Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

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Status unknown
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First seen Sep 09, 2026 · Last updated Sep 09, 2026

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

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Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2023

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The places running it

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  2. The official record

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  3. A doctor treating you

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Contacts and locations

Locations

  • Loewenstein Rehabilitation Hospital

    RECRUITING

    Raanana, Israel

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