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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
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