Hemopatch Versus No Hemopatch (Renal Transplant)

St. Joseph's Healthcare Hamilton

Status: Completed

Conditions: Renal Failure

Treatments: Device: No Hemopatch; Device: Hemopatch

Study type: Interventional

Funder types: Other

Identifiers

NCT02633670

TXNXHEMOPATCH

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Hemopatch

Experimental group

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.

Treatment:

Device: Hemopatch

Standard technique

Active Comparator group

Description:

Standard hemostatic agents (floseal, tisseal).

Treatment:

Device: No Hemopatch