NCT05484557 Prevention of Thromboembolism Using Apixaban vs Enoxaparin Following Spinal Cord Injury
| NCT ID | NCT05484557 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Loewenstein Hospital |
| Condition | Spinal Cord Injuries |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2023-09-06 |
| Primary Completion | 2025-08 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2023-09-06 with a primary completion date of 2025-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05484557 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Spinal Cord Injuries. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05484557 currently recruiting?
Yes, NCT05484557 is actively recruiting participants. Contact the research team at amiramc@clalit.org.il for enrollment information.
Where is the NCT05484557 trial being conducted?
This trial is being conducted at Raanana, Israel.
Who is sponsoring the NCT05484557 clinical trial?
NCT05484557 is sponsored by Loewenstein Hospital. The trial plans to enroll 60 participants.