RecruitingNot ApplicableNCT05484557

Prevention of Thromboembolism Using Apixaban vs Enoxaparin Following Spinal Cord Injury

Sponsor

Loewenstein Hospital

Enrollment

60 participants

Start Date

Sep 6, 2023

Study Type

INTERVENTIONAL

Conditions

Spinal Cord Injuries Spinal Diseases

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares two blood-clot prevention medications — apixaban (a pill) and enoxaparin (an injection) — in patients with spinal cord injuries to see which is safer and more effective at preventing dangerous blood clots (thromboembolism). You may be eligible if: - You have a spinal cord injury (traumatic or non-traumatic) - You speak Hebrew You may NOT be eligible if: - You have a condition that prevents you from taking blood thinners - You are already on other anticoagulant medications - You have active significant bleeding - You are pregnant or breastfeeding - You have kidney problems, severe liver disease with bleeding risk, or antiphospholipid syndrome - You have a prosthetic heart valve or had a recent ischemic stroke - You have active cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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