Hemopatch Versus No Hemopatch (Renal Transplant)

Not Applicable

Completed

• Conditions: Renal Failure
• Interventions: Device: Hemopatch; Device: No Hemopatch

• Registration Number: NCT02633670
• Lead Sponsor: St. Joseph's Healthcare Hamilton

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-12-15
• Study First Submitted QC: 2015-12-16
• Study First Posted: 2015-12-17
• Study Start: 2016-06
• Primary Completion: 2020-03
• Study Completion: 2020-03
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-14
• Last Update Posted: 2021-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Hemopatch	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.
Standard technique	No Hemopatch	Standard hemostatic agents (floseal, tisseal).

Primary Outcome Measures

Name	Time	Method
Blood Loss	Baseline (Intraoperatively)	Blood loss will be measured in ml (cc).

Secondary Outcome Measures

Name	Time	Method
Amount of Perigraft Collection	up to 48 hours postoperative	measured in ml (with ultrasound done within 48 hours of surgery).
Hemostasis achievement	Baseline (Intraoperatively)	Hemostasis achievement will be measured in minutes.
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).

Trial Locations

Locations (1)

Marylrose Gundayao; 🇨🇦 Hamilton, Ontario, Canada