Recruiting

Heparin

Sponsor:

Centre hospitalier de l'Université de Montréal (CHUM)

Code:

NCT04725201

Conditions

Amputation; Traumatic, Hand

Eligibility Criteria

Sex: All

Age: 14+

Healthy Volunteers: Not accepted

Interventions

Intravenous unfractionated heparin

Sham

Study Details

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 ID

NCT04725201

Start date

May 24, 2021

Status verified date

Mar, 2026

Completion date

May 1, 2027

Anticipated

Primary completion date

Mar 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 14+

Healthy Volunteers: Not accepted

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

Enrollment

188 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Intravenous unfractionated heparin

See experimental arm description for intervention description.

Sham

See sham comparator arm description for intervention description.

Primary outcome measure

  • Success of digit replantation or revascularization [ Time Frame: Up to 14 days ]

Central Contacts and Locations

Central contacts

Linda M Zhu

5148908000linda.zhu@mail.mcgill.ca

Locations

CHUM

Recruiting

Montreal, Quebec, Canada, H2X 3E4

Contacts

Linda Zhu

linda.zhu@mail.mcgill.ca

More Information

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Last update posted

Apr 2, 2026

Last verified

Mar, 2026

Keywords

  • Replantation
  • Revascularization
  • Unfractionated heparin
  • Finger

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Centre hospitalier de l'Université de Montréal (CHUM) on 2026-04-02.