Hemopatch Versus No Hemopatch (Renal Transplant)
A Prospective Randomized Trial of Hemopatch Versus No Hemopatch For the Intraoperative Hemostasis During Deceased Donor Renal Transplant
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 15, 2015
CompletedFirst Posted
Study publicly available on registry
December 17, 2015
CompletedStudy Start
First participant enrolled
June 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2020
CompletedDecember 16, 2021
December 1, 2021
3.8 years
December 15, 2015
December 14, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Blood Loss
Blood loss will be measured in ml (cc).
Baseline (Intraoperatively)
Secondary Outcomes (3)
Hemostasis achievement
Baseline (Intraoperatively)
Drop in Hemoglobin
up to 48 hours postoperatively
Amount of Perigraft Collection
up to 48 hours postoperative
Study Arms (2)
Hemopatch
EXPERIMENTALThe 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 technique
ACTIVE COMPARATORStandard hemostatic agents (floseal, tisseal).
Interventions
Eligibility Criteria
You may qualify if:
- Patients at least 18 years of age and capable of giving informed consent
- Patients scheduled for deceased donor renal transplant surgery
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Marylrose Gundayao
Hamilton, Ontario, L8N4A6, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anil Kapoor, MD, FRCSC
McMaster University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, FRCSC
Study Record Dates
First Submitted
December 15, 2015
First Posted
December 17, 2015
Study Start
June 1, 2016
Primary Completion
March 1, 2020
Study Completion
March 1, 2020
Last Updated
December 16, 2021
Record last verified: 2021-12