Prevention of Thromboembolism Using Apixaban vs Enoxaparin Following Spinal Cord Injury

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLoewenstein Hospital

About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Apixaban
  • Enoxaparin Sodium

Treatment groups

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators