Prospective Study on the Role of Intravenous Unfractionated Heparin Following Digital Replantation and Revascularization
Recruiting now · Phase 4 · Has a placebo group
Conditions studied: Amputation; Traumatic, Hand
In brief
The purpose of this study is to determine the effectiveness of therapeutic dose intravenous heparin at improving replantation/revascularization success and its indications (if any) in participants who have suffered traumatic digital amputation. Digital replantation/revascularization success will be assessed in participants who receive continuous intravenous drip of thromboprophylactic heparin at a therapeutic dose (i.e. modifies INR to the desired range) contrasted to those who do not receive therapeutic dose heparin (i.e. does not modify INR to the desired range). In the study, replantation/revascularization success is defined as a clearly viable digit at the time of discharge. Secondary objectives include assessing postoperative complications associated with heparin use, such as bleeding, hematoma or heparin induced thrombocytopenia. The investigators would also assess the impact of categorical variables such as smoking status, mechanism of injury and comorbidities, on digital survival.
Key facts
- Study ID
- NCT04725201
- Run by
- Centre hospitalier de l'Université de Montréal (CHUM)
- People needed
- 188
- Starts
- 2021-05-24
- Expected to finish
- 2027-05-01
- Last updated by the study team
- 2026-04-02
Who can join
Age: 14 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- All replantation and revascularization patients who are accepted into the CEVARMU program at the Centre hospitalier de l'Université de Montréal
You may not qualify if…
- Patients on anticoagulants, other than ASA, prior to admission (i.e. Coumadin, Eliquis, Pradaxa, Plavix, or similar medications)
- Patients with a contraindication for heparin (e.g. coagulopathy, acute ulcers, thrombocytopenia, severe liver damage, shock)
- Patients who suffered an amputation in the level of the carpal tunnel and proximal to it
- Patients who experienced a degloving injury
Where it is running
- CHUM — Montreal, Quebec, Canada (enrolling)
Full record on ClinicalTrials.gov
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