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

• Status: Recruiting
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
• Treatments: Calcium heparin; Heparin

Criteria

Inclusion Criteria:

• All replantation and revascularization patients who are accepted into the CEVARMU program at the Centre hospitalier de l'Université de Montréal

Exclusion Criteria:

• 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