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

Amputation; Traumatic, Hand Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04725201
• Other study ID #: 2021-9178
• Status: Recruiting
• Phase: Phase 4
• Start date: May 24, 2021
• Est. completion date: May 1, 2025

Study information

• Verified date: July 2023
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: Linda M Zhu
• Phone: 5148908000
• Email: linda.zhu[@]mail.mcgill.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 188
• Est. completion date: May 1, 2025
• Est. primary completion date: September 24, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Amputation, Traumatic
• Amputation; Traumatic, Hand

Intervention

Drug:
• Intravenous unfractionated heparin
See experimental arm description for intervention description.
• Sham
See sham comparator arm description for intervention description.

Locations

Country	Name	City	State
Canada	CHUM	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success of digit replantation or revascularization	Success is defined as a clearly viable digit, determined by saturation with a pulse oximeter or by bleeding on needle pinprick.	Up to 14 days
Secondary	Heparin-related complications	Complications include but are not limited to bleeding at or away from site of injury, hematoma, heparin-induced thrombocytopenia.	Up to 14 days