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

Phase 4

Recruiting

• Conditions: Amputation; Traumatic, Hand
• Interventions: Drug: Intravenous unfractionated heparin; Drug: Sham

• Registration Number: NCT04725201
• Lead Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-09
• Study First Submitted QC: 2021-01-24
• Study First Posted: 2021-01-26
• Study Start: 2021-05-24
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-25
• Last Update Posted: 2023-07-27
• Primary Completion: 2024-09-24
• Study Completion: 2025-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 188

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intravenous unfractionated heparin	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.
Control	Sham	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.

Primary Outcome Measures

Name	Time	Method
Success of digit replantation or revascularization	Up to 14 days	Success is defined as a clearly viable digit, determined by saturation with a pulse oximeter or by bleeding on needle pinprick.

Secondary Outcome Measures

Name	Time	Method
Heparin-related complications	Up to 14 days	Complications include but are not limited to bleeding at or away from site of injury, hematoma, heparin-induced thrombocytopenia.

Trial Locations

Locations (1)

CHUM; 🇨🇦 Montreal, Quebec, Canada