Prevention of Thromboembolism Using Apixaban vs Enoxaparin Following Spinal Cord Injury

NCT05484557 | Recruiting

• 1 other identifier: 0023-20-LOE
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries; Spinal Diseases

Outcome Measures

Primary Outcomes (1)

• Number of participants with venous thromboembolism (VTE)

  deep vein thrombosis or pulmonary embolism

  2 years

Secondary Outcomes (1)

• Number of participants with bleeding events.

  6 to 12 weeks

Study Arms (2)

study

EXPERIMENTAL

treatment with Apixaban

Drug: Apixaban

Control

ACTIVE COMPARATOR

treatment with Enoxaparin

Drug: Enoxaparin Sodium

Interventions

Apixaban DRUG

treatment for 6 to 12 weeks

study

Enoxaparin Sodium DRUG

treatment for 6 to 12 weeks

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Loewenstein Hospital: lead

Study Sites (1)

Loewenstein Rehabilitation Hospital

Raanana, Israel

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries; Spinal Diseases

Interventions

apixaban; enoxaparin sodium

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Bone Diseases; Musculoskeletal Diseases

Central Study Contacts

Amiram Catz, MD PhD

CONTACT

972-9-770-9934; amiramc@clalit.org.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the spinal department

Study Record Dates

• First Submitted: July 24, 2022
• First Posted: August 2, 2022
• Study Start: September 6, 2023
• Primary Completion: August 1, 2025
• Study Completion: February 1, 2026
• Last Updated: May 9, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)