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

NCT04725201 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 2021-9178
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 1

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

Keywords

Replantation; Revascularization; Unfractionated heparin; Finger

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Heparin-related complications

  Up to 14 days

Study Arms (2)

Intravenous unfractionated heparin

EXPERIMENTAL

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

Control

SHAM COMPARATOR

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

Interventions

Intravenous unfractionated heparin DRUG

See experimental arm description for intervention description.

Intravenous unfractionated heparin

Sham DRUG

See sham comparator arm description for intervention description.

Control

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All replantation and revascularization patients who are accepted into the CEVARMU program at the Centre hospitalier de l'Université de Montréal

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead

Study Sites (1)

CHUM

Montreal, Quebec, H2X 3E4, Canada

RECRUITING

MeSH Terms

Interventions

salicylhydroxamic acid

Study Officials

• Bruno Mastropasqua, MD FRCSC

  Université de Montréal

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Linda M Zhu

CONTACT

5148908000; linda.zhu@mail.mcgill.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective randomized double-blinded clinical trial

Study Record Dates

• First Submitted: January 9, 2021
• First Posted: January 26, 2021
• Study Start: May 24, 2021
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)