Prevention of Thromboembolism Using Apixaban vs Enoxaparin Following Spinal Cord Injury

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-06

Study Completion Date

2026-02-28

Brief Summary

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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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Detailed Description

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Conditions

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Spinal Cord Injuries Spinal Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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study

treatment with Apixaban

Group Type EXPERIMENTAL

Apixaban

Intervention Type DRUG

treatment for 6 to 12 weeks

Control

treatment with Enoxaparin

Group Type ACTIVE_COMPARATOR

Enoxaparin Sodium

Intervention Type DRUG

treatment for 6 to 12 weeks

Interventions

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Apixaban

treatment for 6 to 12 weeks

Intervention Type DRUG

Enoxaparin Sodium

treatment for 6 to 12 weeks

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No