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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age14+
SponsorCentre hospitalier de l'Université de Montréal (CHUM)

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Intravenous unfractionated heparin

    Drug

    See experimental arm description for intervention description.

  • Sham

    Drug

    See sham comparator arm description for intervention description.

Treatment groups

188 Participants
are divided into 2 treatment groups
Group A: Intravenous unfractionated heparinExperimental treatment 1 intervention
Group B: ControlSham comparator 1 intervention

Trial outcomes

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.

Time frame
Up to 14 days

Secondary outcomes

1

Heparin-related complications

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

Time frame
Up to 14 days

Other outcomes

Sponsors and contacts

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