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Anticoagulant

Heparin for Hand Amputation

Phase 4

Recruiting

Led By Bruno Mastropasqua, MD FRCSC

Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 14 days

Awards & highlights

Study Summary

This trial will test whether therapeutic dose heparin improves replantation/revascularization success rates for people who have suffered a traumatic digital amputation.

Who is the study for?

This trial is for individuals who have undergone hand replantation or revascularization at the Centre hospitalier de l'Université de Montréal. It's not for those with amputations above the wrist, on certain blood thinners, with degloving injuries, or conditions that make heparin use unsafe like bleeding disorders and severe liver damage.Check my eligibility

What is being tested?

The study tests if intravenous unfractionated heparin improves the success of surgically reattached fingers after trauma. Participants are divided into two groups: one receiving a therapeutic dose of heparin and another without it to compare outcomes at discharge.See study design

What are the potential side effects?

Possible side effects from using heparin include increased risk of bleeding, formation of hematomas (blood clots under skin), and a low platelet count condition called heparin-induced thrombocytopenia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 14 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 14 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 14 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Success of digit replantation or revascularization

Secondary outcome measures

Heparin-related complications

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Intravenous unfractionated heparinExperimental Treatment1 Intervention

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.

Group II: ControlPlacebo Group1 Intervention

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.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor

369 Previous Clinical Trials

129,649 Total Patients Enrolled

Bruno Mastropasqua, MD FRCSCPrincipal InvestigatorUniversité de Montréal

Media Library

$Intravenous unfractionated heparin (Anticoagulant) Clinical Trial Eligibility Overview. Trial Name: NCT04725201 — Phase 4$

$Hand Amputation Research Study Groups: Intravenous unfractionated heparin, Control$

$Hand Amputation Clinical Trial 2023: Intravenous unfractionated heparin Highlights & Side Effects. Trial Name: NCT04725201 — Phase 4$

$Intravenous unfractionated heparin (Anticoagulant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04725201 — Phase 4$

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has a trial like this one been conducted before?

"45 different ongoing trials for Intravenous unfractionated heparin exist across 211 cities and 23 countries. The first study was completed in 2006 and involved 415 patients in its Phase 3 stage of drug approval. 301 studies have been conducted in the 14 years since 2006."

Answered by AI

What is the most serious complication that can occur from Intravenous unfractionated heparin?

"Our team at Power estimates that the safety of Intravenous unfractionated heparin is a 3 because this is a Phase 4 trial, meaning this treatment is approved."

Answered by AI

What is unfractionated heparin typically used to alleviate?

"Intravenous unfractionated heparin is most often used to treat medical devices, but can also be used for the treatment of conditions like atrial fibrillation, unstable angina pectoris, and sprains."

Answered by AI

How many study participants will this research include?

"That is accurate, the information available on clinicaltrials.gov attests to the fact that this research is actively looking for participants. The 188 potential patients will be seen at a single site and the study was originally posted on May 24th, 2021 with the most recent update occurring on August 1st, 2022."

Answered by AI

Are there previous examples of Intravenous unfractionated heparin being used in medical research?

"45 different clinical trials are currently underway to study the effects of Intravenous unfractionated heparin. Of these, 15 are in Phase 3. Most of the trials are located in Sherbrooke, Quebec, but there are a total of 389 active clinical trial sites for Intravenous unfractionated heparin."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2021. "Prospective Study on the Role of Intravenous Unfractionated Heparin Following Digital Replantation and Revascularization". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04725201.