NCT04725201

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 188 (estimated)
• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM) · Academic / Other
• Sex: All
• Age: 14 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Amputation; Traumatic, Hand

Interventions

Type	Name	Description
DRUG	Intravenous unfractionated heparin	See experimental arm description for intervention description.
DRUG	Sham	See sham comparator arm description for intervention description.

Timeline

• Start date: 2021-05-24
• Primary completion: 2027-03-01
• Completion: 2027-05-01
• First posted: 2021-01-26
• Last updated: 2026-04-02

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated drug study