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RECRUITING
NCT04725201
PHASE4

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

Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

14 Years - Any

Study Type

INTERVENTIONAL

Enrollment

188

Start Date

2021-05-24

Completion Date

2027-05-01

Last Updated

2026-04-02

Healthy Volunteers

No

Interventions

DRUG

Intravenous unfractionated heparin

See experimental arm description for intervention description.

DRUG

Sham

See sham comparator arm description for intervention description.

Locations (1)

CHUM

Montreal, Quebec, Canada