A prospective, randomized, pilot trial of a polyethylene glycol (PEG)-coated collagen patch (Hemopatch®) for intraoperative hemostasis during deceased donor renal transplant

Abstract

Introduction: The objective of this study was to evaluate the safety and feasibility of using a polyethylene glycol (PEG)-coated collagen patch (Hemopatch®) in patients undergoing deceased donor renal transplant. The primary outcome was the amount of intraoperative estimated blood loss in those patients receiving the patch compared to without. Secondary outcomes were the subjective achievement of hemostasis, perigraft collection, and drop in hemoglobin 48 hours postoperatively. Methods: We performed a single-center, prospective, randomized trial. Patients scheduled to undergo deceased donor renal transplant surgery were randomized to receive the PEG-coated patch or standard hemostasis (i.e., electrocautery and clips). Results: A total of 30 patients were enrolled over 15 months and randomized to receive the PEG-coated patch (n=15) or standard hemostasis (n=15). The mean age was 62.5 years. As determined by the operating surgeon, hemostasis was successfully achieved in all 15 cases using the PEG-coated patch. In the PEG-coated patch group, there was a trend towards less estimated blood loss (237 cc vs. 327 cc; p=0.11) and a lower drop in hemoglobin 48 hours postoperatively (22.27 g/L vs. 29.53 g/L; p=0.09) compared to the standard hemostasis group. Perigraft collection was similar between groups (27% vs. 40%; p=0.43). Subgroup analysis on patients who received anticoagulation therapy revealed no significant difference in blood loss between groups. Conclusions: Based on our single-center experience, the PEG-coated patch (Hemopatch®) is a safe and feasible option to aid hemostasis during deceased donor renal transplant surgery. Hemostasis was successfully achieved in all cases using the PEG-coated patch.