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NCT Number: NCT05484557

Prevention of Thromboembolism Using Apixaban vs Enoxaparin Following Spinal Cord Injury

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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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Loewenstein Rehabilitation Hospital

Raanana, Israel

Location status: Recruiting

Location contact

Sara Lipkin

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Apixaban

Drug

treatment for 6 to 12 weeks

Enoxaparin sodium

Drug

treatment for 6 to 12 weeks

Primary outcomes

  1. Number of participants with venous thromboembolism (VTE)

    Time frame: 2 years

    deep vein thrombosis or pulmonary embolism

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Amiram Catz, MD PhD

CONTACT

[email protected]

972-9-770-9934

Sponsors and collaborators

Lead sponsor

Loewenstein Hospital

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Aug 2, 2022
Registry last updated
May 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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