Hemopatch Versus No Hemopatch (Renal Transplant)

A Prospective Randomized Trial of Hemopatch Versus No Hemopatch For the Intraoperative Hemostasis During Deceased Donor Renal Transplant

Kidney transplantation remains one of the most common organ transplanted today but the surgical technique has changed very little from the original pelvic operation. The deceased donor renal transplant poses a particular challenge to the surgeon due to lack of detailed pre operative vascular assessment. The hemopatch is a promising new sealing synthetic hemostatIc agent with a novel dual mechanism of action that is more convenient to apply rather then using other hemostatic agents, which require warming and/or mixing.

Study Overview

• Status: Completed
• Conditions: Renal Failure
• Intervention / Treatment: Device: Hemopatch; Device: No Hemopatch

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8N4A6
      • Marylrose Gundayao

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients at least 18 years of age and capable of giving informed consent
• Patients scheduled for deceased donor renal transplant surgery

Exclusion Criteria:

• Patient undergoing live related transplant surgery.
• Patient having uncorrectable bleeding diathesis.
• Any patient in the no hemopatch group requiring additional haemostatic agents for achieving hemostasis like fibrillar or surgical.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hemopatch; The hemopatch is a promising new sealing synthetic hemostatic agent with a noval dual mechanism of action. The hemopatch is a polyethylene glycol coated (PEG coated) collagen patch. The PEG coating helps in rapid adhesion to the tissue surface while the collagen layer causes platelet activation and adhesion.	Device: Hemopatch
Active Comparator: Standard technique; Standard hemostatic agents (floseal, tisseal).	Device: No Hemopatch

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Loss	Blood loss will be measured in ml (cc).	Baseline (Intraoperatively)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemostasis achievement	Hemostasis achievement will be measured in minutes.	Baseline (Intraoperatively)
Drop in Hemoglobin	Hemoglobin will be measured in g/L (drop measured from pre-operative levels to post-operative 48 hours).	up to 48 hours postoperatively
Amount of Perigraft Collection	measured in ml (with ultrasound done within 48 hours of surgery).	up to 48 hours postoperative

Collaborators and Investigators

• Sponsor: St. Joseph's Healthcare Hamilton

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Actual): March 1, 2020
• Study Completion (Actual): March 1, 2020

Study Registration Dates

• First Submitted: December 15, 2015
• First Submitted That Met QC Criteria: December 16, 2015
• First Posted (Estimate): December 17, 2015

Study Record Updates

• Last Update Posted (Actual): December 16, 2021
• Last Update Submitted That Met QC Criteria: December 14, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency
• Other Study ID Numbers: TXNXHEMOPATCH