Hemopatch Versus No Hemopatch (Renal Transplant)

Renal Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02633670
• Other study ID #: TXNXHEMOPATCH
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: March 2020

Study information

• Verified date: December 2021
• Source: St. Joseph's Healthcare Hamilton
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Renal Failure
• Renal Insufficiency

Intervention

Device:
• Hemopatch

• No Hemopatch

Locations

Country	Name	City	State
Canada	Marylrose Gundayao	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
St. Joseph's Healthcare Hamilton

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Loss	Blood loss will be measured in ml (cc).	Baseline (Intraoperatively)
Secondary	Hemostasis achievement	Hemostasis achievement will be measured in minutes.	Baseline (Intraoperatively)
Secondary	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
Secondary	Amount of Perigraft Collection	measured in ml (with ultrasound done within 48 hours of surgery).	up to 48 hours postoperative