NCT04725201 Prospective Study on the Role of Intravenous Unfractionated Heparin Following Digital Replantation and Revascularization
| NCT ID | NCT04725201 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Centre hospitalier de l'Université de Montréal (CHUM) |
| Condition | Amputation; Traumatic, Hand |
| Study Type | INTERVENTIONAL |
| Enrollment | 188 participants |
| Start Date | 2021-05-24 |
| Primary Completion | 2027-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 188 participants in total. It began in 2021-05-24 with a primary completion date of 2027-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Bruno Mastropasqua, MD FRCSC
PRINCIPAL INVESTIGATOR
Université de Montréal
Frequently Asked Questions
Who can join the NCT04725201 clinical trial?
This trial is open to participants of all sexes, aged 14 Years or older, studying Amputation; Traumatic, Hand. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04725201 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT04725201 currently recruiting?
Yes, NCT04725201 is actively recruiting participants. Contact the research team at linda.zhu@mail.mcgill.ca for enrollment information.
Where is the NCT04725201 trial being conducted?
This trial is being conducted at Montreal, Canada.
Who is sponsoring the NCT04725201 clinical trial?
NCT04725201 is sponsored by Centre hospitalier de l'Université de Montréal (CHUM). The principal investigator is Bruno Mastropasqua, MD FRCSC at Université de Montréal. The trial plans to enroll 188 participants.