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

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM) (Other)

Overall Status

Recruiting

CT.gov ID

NCT04725201

Collaborator

(none)

188

Enrollment

Location

Arms

27.3

Anticipated Duration (Months)

6.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Amputation; Traumatic, Hand	Drug: Intravenous unfractionated heparin Drug: Sham	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

188 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Prospective randomized double-blinded clinical trialProspective randomized double-blinded clinical trial

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 24, 2021

Anticipated Primary Completion Date :

May 24, 2023

Anticipated Study Completion Date :

Sep 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intravenous unfractionated heparin 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.	Drug: Intravenous unfractionated heparin See experimental arm description for intervention description.
Sham Comparator: Control 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.	Drug: Sham See sham comparator arm description for intervention description.

Arm

Intervention/Treatment

Experimental: Intravenous unfractionated heparin

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.

Drug: Intravenous unfractionated heparin

See experimental arm description for intervention description.

Sham Comparator: Control

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.

Drug: Sham

See sham comparator arm description for intervention description.

Outcome Measures

Primary Outcome Measures

Success of digit replantation or revascularization [Up to 14 days]
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 [Up to 14 days]
Complications include but are not limited to bleeding at or away from site of injury, hematoma, heparin-induced thrombocytopenia.

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years and Older

Sexes Eligible for Study:

All

Accepts 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