Using heparin to improve success after finger replantation
Prospective Study on the Role of Intravenous Unfractionated Heparin Following Digital Replantation and Revascularization
PHASE4 · Centre hospitalier de l'Université de Montréal (CHUM) · NCT04725201
This study is testing if giving heparin through an IV can help improve the chances of success for people who have had their fingers amputated and are getting them reattached.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 188 (estimated) |
| Ages | 14 Years and up |
| Sex | All |
| Sponsor | Centre hospitalier de l'Université de Montréal (CHUM) (other) |
| Locations | 1 site (Montreal, Quebec) |
| Trial ID | NCT04725201 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of intravenous unfractionated heparin in enhancing the success rates of digital replantation and revascularization in patients who have experienced traumatic finger amputations. Participants will receive a continuous intravenous drip of heparin to assess its impact on the viability of the replanted digit compared to those who do not receive the treatment. The study will also evaluate potential postoperative complications associated with heparin use, such as bleeding and thrombocytopenia, while considering various patient factors like smoking status and comorbidities.
Who should consider this trial
Good fit: Ideal candidates are individuals who have undergone traumatic digital amputation and are accepted into the replantation program at the Centre hospitalier de l'Université de Montréal.
Not a fit: Patients on anticoagulants or with contraindications for heparin, as well as those with more severe injuries, will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the outcomes of finger replantation surgeries, leading to better recovery and functionality for patients.
How similar studies have performed: While the use of heparin in this specific context is novel, similar studies in other surgical fields have shown promising results with anticoagulant therapies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Montreal, Quebec
- CHUM — Montreal, Quebec, Canada (RECRUITING)
Study contacts
- Principal investigator: Bruno Mastropasqua, MD FRCSC — Université de Montréal
- Study coordinator: Linda M Zhu
- Email: linda.zhu@mail.mcgill.ca
- Phone: 5148908000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Amputation, Traumatic, Hand, Replantation, Revascularization, Unfractionated heparin, Finger