Prevention of Thromboembolism Using Apixaban vs Enoxaparin Following Spinal Cord Injury
Loewenstein Hospital
60 participants
Sep 6, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria1
- spinal cord injury (traumatic of not traumatic), Hebrew speaker.
Exclusion Criteria16
- 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
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Interventions
treatment for 6 to 12 weeks
treatment for 6 to 12 weeks
Locations(1)
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NCT05484557