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

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.

Study Overview

• Status: Recruiting
• Conditions: Amputation; Traumatic, Hand
• Intervention / Treatment: Drug: Intravenous unfractionated heparin; Drug: Sham

• Study Type: Interventional
• Enrollment (Estimated): 188
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Linda M Zhu; Phone Number: 5148908000; Email: linda.zhu@mail.mcgill.ca

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H2X 3E4
      • Recruiting
      • CHUM
      • Contact: Linda Zhu; Email: linda.zhu@mail.mcgill.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Intravenous unfractionated heparin; See experimental arm description for intervention description.
Sham Comparator: 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.	Drug: Sham; See sham comparator arm description for intervention description.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
• Investigators: Principal Investigator: Bruno Mastropasqua, MD FRCSC, Université de Montréal

Study record dates

Study Major Dates

• Study Start (Actual): May 24, 2021
• Primary Completion (Estimated): September 24, 2024
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: January 9, 2021
• First Submitted That Met QC Criteria: January 24, 2021
• First Posted (Actual): January 26, 2021

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 25, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Revascularization; Unfractionated heparin; Finger; Replantation
• Additional Relevant MeSH Terms: Wounds and Injuries; Amputation, Traumatic; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Anticoagulants; Heparin; Calcium heparin
• Other Study ID Numbers: 2021-9178

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes