Back to resultsPrevention of Thromboembolism Using Apixaban vs Enoxaparin Following Spinal Cord Injury
Primary Purpose
Spinal Cord Injuries, Spinal Diseases
Status
Recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Apixaban
Enoxaparin Sodium
Sponsored by
About this trial
This is an interventional prevention trial for Spinal Cord Injuries
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
Sites / Locations
- Loewenstein Rehabilitation HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
study
Control
Arm Description
treatment with Apixaban
treatment with Enoxaparin
Outcomes
Primary Outcome Measures
Number of participants with venous thromboembolism (VTE)
deep vein thrombosis or pulmonary embolism
Secondary Outcome Measures
Number of participants with bleeding events.
bleeding occurrence (decrease of hemoglobin by at least 1 g/dL) during the medication period.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05484557
Brief Title
Prevention of Thromboembolism Using Apixaban vs Enoxaparin Following Spinal Cord Injury
Official Title
Prevention of Thromboembolism Using Apixaban vs Enoxaparin Following Spinal Cord Injury
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 6, 2023 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
February 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Loewenstein Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries, Spinal Diseases
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
study
Arm Type
Experimental
Arm Description
treatment with Apixaban
Arm Title
Control
Arm Type
Active Comparator
Arm Description
treatment with Enoxaparin
Intervention Type
Drug
Intervention Name(s)
Apixaban
Intervention Description
treatment for 6 to 12 weeks
Intervention Type
Drug
Intervention Name(s)
Enoxaparin Sodium
Intervention Description
treatment for 6 to 12 weeks
Primary Outcome Measure Information:
Title
Number of participants with venous thromboembolism (VTE)
Description
deep vein thrombosis or pulmonary embolism
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Number of participants with bleeding events.
Description
bleeding occurrence (decrease of hemoglobin by at least 1 g/dL) during the medication period.
Time Frame
6 to 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amiram Catz, MD PhD
Phone
972-9-770-9934
Email
amiramc@clalit.org.il
Facility Information:
Facility Name
Loewenstein Rehabilitation Hospital
City
Ra'anana
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sara Lipkin
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Prevention of Thromboembolism Using Apixaban vs Enoxaparin Following Spinal Cord Injury
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