Prevention of Thromboembolism Using Apixaban vs Enoxaparin Following Spinal Cord Injury
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Apixaban, Enoxaparin Sodium.
- Who it may be relevant to
- Registry conditions: Spinal Cord Injuries, Spinal Diseases. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Israel
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug Apixaban
treatment for 6 to 12 weeks - Drug Enoxaparin Sodium
treatment for 6 to 12 weeks
Primary outcome measures
- Number of participants with venous thromboembolism (VTE) [Time frame: 2 years]
Secondary outcome measures (1)
- Number of participants with bleeding events. [Time frame: 6 to 12 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Israel · 1 center
- Loewenstein Rehabilitation Hospital — Raanana
Identifiers
NCT: NCT05484557 · 0023-20-LOE