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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
60
treatment for 6 to 12 weeks
treatment for 6 to 12 weeks
Loewenstein Rehabilitation Hospital
Raanana, Israel
RECRUITINGNumber of participants with venous thromboembolism (VTE)
deep vein thrombosis or pulmonary embolism
Time frame: 2 years
Number of participants with bleeding events.
bleeding occurrence (decrease of hemoglobin by at least 1 g/dL) during the medication period.
Time frame: 6 to 12 weeks
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