Prevention of Thromboembolism Using Apixaban vs Enoxaparin Following Spinal Cord Injury

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)

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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