Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05484557
Other study ID # 0023-20-LOE
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT06321172 - Muscle and Bone Changes After 6 Months of FES Cycling N/A
Completed NCT03457714 - Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
Suspended NCT05542238 - The Effect of Acute Exercise on Cardiac Autonomic, Cerebrovascular, and Cognitive Function in Spinal Cord Injury N/A
Recruiting NCT05503316 - The Roll of Balance Confidence in Gait Rehabilitation in Persons With a Lesion of the Central Nervous System N/A
Not yet recruiting NCT05506657 - Early Intervention to Promote Return to Work for People With Spinal Cord Injury N/A
Recruiting NCT04105114 - Transformation of Paralysis to Stepping Early Phase 1
Recruiting NCT03680872 - Restoring Motor and Sensory Hand Function in Tetraplegia Using a Neural Bypass System N/A
Completed NCT04221373 - Exoskeletal-Assisted Walking in SCI Acute Inpatient Rehabilitation N/A
Completed NCT00116337 - Spinal Cord Stimulation to Restore Cough N/A
Completed NCT03898700 - Coaching for Caregivers of Children With Spinal Cord Injury N/A
Recruiting NCT04883463 - Neuromodulation to Improve Respiratory Function in Cervical Spinal Cord Injury N/A
Active, not recruiting NCT04881565 - Losing Balance to Prevent Falls After Spinal Cord Injury (RBT+FES) N/A
Completed NCT04864262 - Photovoice for Spinal Cord Injury to Prevent Falls N/A
Recruiting NCT04007380 - Psychosocial, Cognitive, and Behavioral Consequences of Sleep-disordered Breathing After SCI N/A
Active, not recruiting NCT04544761 - Resilience in Persons Following Spinal Cord Injury
Completed NCT03220451 - Use of Adhesive Elastic Taping for the Therapy of Medium/Severe Pressure Ulcers in Spinal Cord Injured Patients N/A
Terminated NCT03170557 - Randomized Comparative Trial for Persistent Pain in Spinal Cord Injury: Acupuncture vs Aspecific Needle Skin Stimulation N/A
Recruiting NCT04811235 - Optical Monitoring With Near-Infrared Spectroscopy for Spinal Cord Injury Trial N/A
Recruiting NCT04736849 - Epidural and Dorsal Root Stimulation in Humans With Spinal Cord Injury N/A
Active, not recruiting NCT05558254 - ROBERT® as an Intervention to Enhance Muscle Strength After Spinal Cord Injury N/A