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Prospective Study on the Role of Intravenous Unfractionated Heparin Following Digital Replantation and Revascularization
Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
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
Conditions
Interventions
Intravenous unfractionated heparin
See experimental arm description for intervention description.
Sham
See sham comparator arm description for intervention description.
Locations (1)
CHUM
Montreal, Quebec, Canada