Apixaban For Thromboprophylaxis In Patients With Acute Spinal Cord Injury
Status:
Terminated
Trial end date:
2019-08-01
Target enrollment:
Participant gender:
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.