A Prospective Randomized Trial of Hemopatch Versus No Hemopatch For the Intraoperative Hemostasis During Deceased Donor Renal Transplant
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Blood Loss
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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.
Arms & Interventions
Standard technique
Standard hemostatic agents (floseal, tisseal).
Intervention: No Hemopatch (Device)
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.
Intervention: Hemopatch (Device)
Outcomes
Primary Outcomes
Blood Loss
Time Frame: Baseline (Intraoperatively)
Blood loss will be measured in ml (cc).
Secondary Outcomes
- Amount of Perigraft Collection(up to 48 hours postoperative)
- Hemostasis achievement(Baseline (Intraoperatively))
- Drop in Hemoglobin(up to 48 hours postoperatively)
Investigators
Anil Kapoor
MD, FRCSC
St. Joseph's Healthcare Hamilton