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

Primary Purpose

Amputation; Traumatic, Hand

Status
Recruiting
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Intravenous unfractionated heparin
Sham
Sponsored by
Centre hospitalier de l'Université de Montréal (CHUM)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Amputation; Traumatic, Hand focused on measuring Replantation, Revascularization, Unfractionated heparin, Finger

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHUMRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Intravenous unfractionated heparin

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
January 9, 2021
Last Updated
July 25, 2023
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
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1. Study Identification

Unique Protocol Identification Number
NCT04725201
Brief Title
Prospective Study on the Role of Intravenous Unfractionated Heparin Following Digital Replantation and Revascularization
Official Title
Prospective Study on the Role of Intravenous Unfractionated Heparin Following Digital Replantation and Revascularization
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 24, 2021 (Actual)
Primary Completion Date
September 24, 2024 (Anticipated)
Study Completion Date
May 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amputation; Traumatic, Hand
Keywords
Replantation, Revascularization, Unfractionated heparin, Finger

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Prospective randomized double-blinded clinical trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
188 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intravenous unfractionated heparin
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Intravenous unfractionated heparin
Intervention Description
See experimental arm description for intervention description.
Intervention Type
Drug
Intervention Name(s)
Sham
Intervention Description
See sham comparator arm description for intervention description.
Primary Outcome Measure Information:
Title
Success of digit replantation or revascularization
Description
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 Outcome Measure Information:
Title
Heparin-related complications
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Linda M Zhu
Phone
5148908000
Email
linda.zhu@mail.mcgill.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruno Mastropasqua, MD FRCSC
Organizational Affiliation
Université de Montréal
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHUM
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 3E4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linda Zhu
Email
linda.zhu@mail.mcgill.ca

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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