Prevention of Thromboembolism Using Apixaban vs Enoxaparin Following Spinal Cord Injury

Spinal Cord Injuries Clinical Trial

Official title:

Prevention of Thromboembolism Using Apixaban vs Enoxaparin Following Spinal Cord Injury

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05484557
• Other study ID #: 0023-20-LOE
• Status: Recruiting
• Phase: N/A
• Start date: September 6, 2023
• Est. completion date: February 2025

Study information

• Verified date: September 2023
• Source: Loewenstein Hospital
• Contact: Amiram Catz, MD PhD
• Phone: 972-9-770-9934
• Email: amiramc[@]clalit.org.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: February 2025
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Diseases
• Thromboembolism
• Wounds and Injuries

Intervention

Drug:
• Apixaban
treatment for 6 to 12 weeks
• Enoxaparin Sodium
treatment for 6 to 12 weeks

Locations

Country	Name	City	State
Israel	Loewenstein Rehabilitation Hospital	Ra'anana

Sponsors (1)

Lead Sponsor	Collaborator
Loewenstein Hospital

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with venous thromboembolism (VTE)	deep vein thrombosis or pulmonary embolism	2 years
Secondary	Number of participants with bleeding events.	bleeding occurrence (decrease of hemoglobin by at least 1 g/dL) during the medication period.	6 to 12 weeks