Health TrialsbyHealthPanel

Prevention of Thromboembolism Using Apixaban vs Enoxaparin Following Spinal Cord Injury

ConditionsSpinal Cord InjuriesSpinal Diseases
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Apixaban

    Drug

    treatment for 6 to 12 weeks

  • Enoxaparin Sodium

    Drug

    treatment for 6 to 12 weeks

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: studyExperimental treatment 1 intervention
Group B: ControlActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of participants with venous thromboembolism (VTE)

deep vein thrombosis or pulmonary embolism

Time frame
2 years

Secondary outcomes

1

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Loewenstein Hospital

Lead sponsor

Source ClinicalTrials.gov
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