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NCT Number: NCT04725201

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.

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Key information

Conditions

Amputation; Traumatic, Hand

Age range

14 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

CHUM

Montreal, Quebec, H2X 3E4, Canada

Location status: Recruiting

Location contact

Linda Zhu

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intravenous unfractionated heparin

Drug

See experimental arm description for intervention description.

sham

Drug

See sham comparator arm description for intervention description.

Primary outcomes

  1. Success of digit replantation or revascularization

    Time frame: 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 outcomes

  1. Heparin-related complications

    Time frame: Up to 14 days

    Complications include but are not limited to bleeding at or away from site of injury, hematoma, heparin-induced thrombocytopenia.

Study contacts

Contact information is provided by the study sponsor or research team.

Linda M Zhu

CONTACT

[email protected]

5148908000

Sponsors and collaborators

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Other

Registry information

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Jan 26, 2021
Registry last updated
Apr 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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