Prevention of Thromboembolism Using Apixaban vs Enoxaparin Following Spinal Cord Injury

Not Applicable

Recruiting

• Conditions: Spinal Cord Injuries; Spinal Diseases
• Interventions: Drug: Apixaban; Drug: Enoxaparin Sodium

• Registration Number: NCT05484557
• Lead Sponsor: Loewenstein Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-24
• Study First Submitted QC: 2022-08-01
• Study First Posted: 2022-08-02
• Study Start: 2023-09-06
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-06
• Last Update Posted: 2025-05-09
• Primary Completion: 2025-08
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
study	Apixaban	treatment with Apixaban
Control	Enoxaparin Sodium	treatment with Enoxaparin

Primary Outcome Measures

Name	Time	Method
Number of participants with venous thromboembolism (VTE)	2 years	deep vein thrombosis or pulmonary embolism

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Loewenstein Rehabilitation Hospital; 🇮🇱 Ra'anana, Israel