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Prevention of Thromboembolism Using Apixaban vs Enoxaparin Following Spinal Cord Injury

RecruitingNAAges 18 Years - anyAllLoewenstein Hospital
NCT05484557 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * spinal cord injury (traumatic of not traumatic), Hebrew speaker. Exclusion Criteria: * 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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What it tests

  • Apixaban
  • Enoxaparin Sodium
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Where

1 site
Loewenstein Rehabilitation Hospital
Raanana, Israel
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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