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

NCT ID: NCT04725201

Last Updated: 2023-07-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 188 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-24
• Study Completion Date: 2025-05-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Intravenous unfractionated heparin

Administration of intravenous unfractionated heparin according to the Centre hospitalier de l'Université de Montréal (CHUM) deep vein thrombosis (DVT) protocol for 5 days after vascular anastomosis. A bolus will be administered intraoperatively based on the patient's weight. Dosages will be adjusted according to the activated partial thromboplastin time (aim for an APTT of 50-70), which will be measured 6 hours after the start of the protocol and after every dosage adjustment or every morning at 6 a.m. if no adjustments were made in the last 6 hours.

Group Type: EXPERIMENTAL

Intravenous unfractionated heparin

Intervention Type: DRUG

See experimental arm description for intervention description.

Control

No administration of intravenous unfractionated heparin. These patients receive 5000 IU BID of heparin subcutaneously, as a standard post-operative protocol for all in-patients.

The control group receives sham bolus intraoperatively of normal saline and a post-operative normal saline infusion at a fixed dose through an infusion pump to mimic IV heparin infusion.

Group Type: SHAM_COMPARATOR

Sham

Intervention Type: DRUG

See sham comparator arm description for intervention description.

Interventions

Intravenous unfractionated heparin

See experimental arm description for intervention description.

Intervention Type: DRUG

Sham

See sham comparator arm description for intervention description.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre hospitalier de l'Université de Montréal (CHUM)

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bruno Mastropasqua, MD FRCSC

Role: PRINCIPAL_INVESTIGATOR

Université de Montréal

Locations

CHUM

Montreal, Quebec, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Linda M Zhu

Role: CONTACT

linda.zhu@mail.mcgill.ca

5148908000

Facility Contacts

Linda Zhu

Role: primary

linda.zhu@mail.mcgill.ca

Other Identifiers

2021-9178

Identifier Type: -

Identifier Source: org_study_id