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Hemopatch Versus No Hemopatch (Renal Transplant)

Primary Purpose

Renal Failure

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Hemopatch
No Hemopatch
Sponsored by
St. Joseph's Healthcare Hamilton
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Failure

Eligibility Criteria

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

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.

Sites / Locations

  • Marylrose Gundayao

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Hemopatch

Standard technique

Arm Description

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.

Standard hemostatic agents (floseal, tisseal).

Outcomes

Primary Outcome Measures

Blood Loss
Blood loss will be measured in ml (cc).

Secondary Outcome Measures

Hemostasis achievement
Hemostasis achievement will be measured in minutes.
Drop in Hemoglobin
Hemoglobin will be measured in g/L (drop measured from pre-operative levels to post-operative 48 hours).
Amount of Perigraft Collection
measured in ml (with ultrasound done within 48 hours of surgery).

Full Information

First Posted
December 15, 2015
Last Updated
December 14, 2021
Sponsor
St. Joseph's Healthcare Hamilton
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1. Study Identification

Unique Protocol Identification Number
NCT02633670
Brief Title
Hemopatch Versus No Hemopatch (Renal Transplant)
Official Title
A Prospective Randomized Trial of Hemopatch Versus No Hemopatch For the Intraoperative Hemostasis During Deceased Donor Renal Transplant
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
June 2016 (undefined)
Primary Completion Date
March 2020 (Actual)
Study Completion Date
March 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Joseph's Healthcare Hamilton

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hemopatch
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard technique
Arm Type
Active Comparator
Arm Description
Standard hemostatic agents (floseal, tisseal).
Intervention Type
Device
Intervention Name(s)
Hemopatch
Intervention Type
Device
Intervention Name(s)
No Hemopatch
Primary Outcome Measure Information:
Title
Blood Loss
Description
Blood loss will be measured in ml (cc).
Time Frame
Baseline (Intraoperatively)
Secondary Outcome Measure Information:
Title
Hemostasis achievement
Description
Hemostasis achievement will be measured in minutes.
Time Frame
Baseline (Intraoperatively)
Title
Drop in Hemoglobin
Description
Hemoglobin will be measured in g/L (drop measured from pre-operative levels to post-operative 48 hours).
Time Frame
up to 48 hours postoperatively
Title
Amount of Perigraft Collection
Description
measured in ml (with ultrasound done within 48 hours of surgery).
Time Frame
up to 48 hours postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anil Kapoor, MD, FRCSC
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Marylrose Gundayao
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N4A6
Country
Canada

12. IPD Sharing Statement

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Hemopatch Versus No Hemopatch (Renal Transplant)

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