Hemopatch Versus No Hemopatch (Renal Transplant)

• Sponsor: St. Joseph's Healthcare Hamilton (Other)
• Overall Status: Completed
• CT.gov ID: NCT02633670
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Duration (Months): 45
• Patients Per Site Per Month: 0.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Renal Failure	Device: Hemopatch; Device: No Hemopatch	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: A Prospective Randomized Trial of Hemopatch Versus No Hemopatch For the Intraoperative Hemostasis During Deceased Donor Renal Transplant
• Study Start Date: Jun 1, 2016
• Actual Primary Completion Date: Mar 1, 2020
• Actual Study Completion Date: Mar 1, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Blood Loss [Baseline (Intraoperatively)]

   Blood loss will be measured in ml (cc).

Secondary Outcome Measures

1. Hemostasis achievement [Baseline (Intraoperatively)]

   Hemostasis achievement will be measured in minutes.

2. Drop in Hemoglobin [up to 48 hours postoperatively]

   Hemoglobin will be measured in g/L (drop measured from pre-operative levels to post-operative 48 hours).

3. Amount of Perigraft Collection [up to 48 hours postoperative]

   measured in ml (with ultrasound done within 48 hours of surgery).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Marylrose Gundayao	Hamilton	Ontario	Canada	L8N4A6

Sponsors and Collaborators

• St. Joseph's Healthcare Hamilton

Investigators

• Principal Investigator: Anil Kapoor, MD, FRCSC, McMaster University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Anil Kapoor, MD, FRCSC, St. Joseph's Healthcare Hamilton
• ClinicalTrials.gov Identifier: NCT02633670
• Other Study ID Numbers: TXNXHEMOPATCH
• First Posted: Dec 17, 2015
• Last Update Posted: Dec 16, 2021
• Last Verified: Dec 1, 2021

• Additional relevant MeSH terms: Renal Insufficiency

Study Results

No Results Posted as of Dec 16, 2021