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Prevention of Thromboembolism Using Apixaban vs Enoxaparin Following Spinal Cord Injury

L

Loewenstein Hospital

Status

Enrolling

Conditions

Spinal Cord Injuries
Spinal Diseases

Treatments

Drug: Apixaban
Drug: Enoxaparin Sodium

Study type

Interventional

Funder types

Other

Identifiers

NCT05484557
0023-20-LOE

Details and patient eligibility

About

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 end of the treatment. Bleeding events will be recorded and hematocrit will be monitored every two weeks.

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

study
Experimental group
Description:
treatment with Apixaban
Treatment:
Drug: Apixaban
Control
Active Comparator group
Description:
treatment with Enoxaparin
Treatment:
Drug: Enoxaparin Sodium

Trial contacts and locations

1

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Central trial contact

Amiram Catz, MD PhD

Data sourced from clinicaltrials.gov

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