Apixaban For Thromboprophylaxis In Patients With Acute Spinal Cord Injury

• Status: Terminated
• Trial end date: 2019-08-01
• Target enrollment: 0
• Participant gender: All

Summary

Thromboprophylaxis options are limited for patients with acute spinal cord injury (SCI) and there are no studies on direct oral anticoagulants (DOACs) for thromboprophylaxis in this population. Participants will be randomized to apixaban 2.5 mg twice daily or standard dose low-molecular-weight heparin (LMWH), either enoxaparin 40 mg or dalteparin 5000 units, subcutaneously once daily for 90 days or until fully mobilized, whatever comes first. Thromboprophylaxis will be started as soon as hemostasis is achieved. The primary outcome for this pilot study will be the recruitment rate per year (i.e. the screened to enrolled ratio). The primary efficacy endpoint will be a composite of symptomatic, objectively verified, venous thromboembolism (VTE), defined as upper or lower limb deep vein thrombosis (DVT) and/or pulmonary embolism (PE) or sudden death where PE cannot be excluded. The primary safety endpoint will be major bleeding.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: McMaster University
• Treatments: Apixaban; Calcium heparin; Dalteparin; Heparin; Heparin, Low-Molecular-Weight; Tinzaparin

Criteria

Inclusion Criteria:

• Adult patients (≥18 years old) with acute spinal cord injury (SCI) presenting to the hospital within 1 week of SCI and is at least 36 h after the injury

• Traumatic SCI

• SCI with or without other injuries

Exclusion Criteria:

• Already on therapeutic oral anticoagulation prior to enrollment

• Active bleeding, intracranial or perispinal hematoma, or acquired or congenital bleeding disorder

• Pregnancy or breast feeding

• Severe renal failure (creatinine clearance ≤30 ml/min)

• Liver cirrhosis

• Severe thrombocytopenia (platelets <50)

• Attending physician believes that the patient is not suitable for the study (for example, psychiatric disorder; history of non-compliance)

• Geographic inaccessibility: planned transfer to other site where follow-up not possible

• Failure to obtain written consent

• Previous hypersensitivity reaction to study drugs

• Patients with expected short hospital admission (≤7 days) due to minor injury