Prevention of Thromboembolism Using Apixaban vs Enoxaparin Following Spinal Cord Injury

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• spinal cord injury (traumatic of not traumatic), Hebrew speaker.

Locations
Other Locations
Israel
Loewenstein Rehabilitation Hospital
RECRUITING
Raanana
Contact Information
Primary
Amiram Catz, MD PhD
amiramc@clalit.org.il
972-9-770-9934
Time Frame
Start Date: 2023-09-06
Estimated Completion Date: 2026-02
Participants
Target number of participants: 60
Treatments
Experimental: study
treatment with Apixaban
Active_comparator: Control
treatment with Enoxaparin
Related Therapeutic Areas
Sponsors
Leads: Loewenstein Hospital

This content was sourced from clinicaltrials.gov