Clinical Trial

Prospective Study on the Role of Intravenous Unfractionated Heparin Following Digital Replantation and Revascularization

Recruiting Phase 4
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Summary
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.
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2021-01-24; most recent amendment 2026-03-27.
Status change: Not Yet Recruiting → Recruiting 2021-05-27
Trial Details
NCT Number NCT04725201
Lead Sponsor Centre hospitalier de l'Université de Montréal (CHUM)
Conditions Amputation; Traumatic, Hand
Enrollment 188 participants
Start Date 2021-05-24
Primary Completion 2027-03-01 (estimated)
Study Completion 2027-05-01 (estimated)
Updated on ClinicalTrials.gov 2026-04-02