Comparing Apixaban and Enoxaparin for preventing blood clots after spinal cord injury
Prevention of Thromboembolism Using Apixaban vs Enoxaparin Following Spinal Cord Injury
This study is testing if a new blood thinner called Apixaban works better than the usual treatment, Enoxaparin, to prevent blood clots in people recovering from spinal cord injuries.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Loewenstein Hospital Academic / other |
| Locations | 1 site (Raanana) |
| Trial ID | NCT05484557 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of Apixaban compared to the standard treatment of Enoxaparin in preventing venous thromboembolism in patients recovering from spinal cord injuries. Participants in the sub-acute phase of spinal cord injury will receive either Enoxaparin or Apixaban for a duration of 6 to 12 weeks, depending on their injury severity. The study will monitor thromboembolism through D-Dimer tests and ultrasound doppler assessments, while also tracking any bleeding events and hematocrit levels throughout the treatment period.
Who should consider this trial
Good fit: Ideal candidates are Hebrew-speaking individuals who have sustained a spinal cord injury and do not have contraindications for anticoagulant treatment.
Not a fit: Patients with active bleeding, significant bleeding risks, or those requiring other anticoagulant treatments will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective anticoagulant option for preventing blood clots in spinal cord injury patients.
How similar studies have performed: While the use of anticoagulants in spinal cord injury is established, the specific comparison of Apixaban and Enoxaparin in this context is a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Raanana
- Loewenstein Rehabilitation Hospital — Raanana, Israel (Recruiting)
Study contacts
- Study coordinator: Amiram Catz, MD PhD
- Email: amiramc@clalit.org.il
- Phone: 972-9-770-9934
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.