A prospective, randomized, pilot trial of a polyethylene glycol (PEG)-coated collagen patch for intraoperative hemostasis during deceased donor renal transplant.Kapoor, A., et al. (2019).
Canadian Urological Association Journal [record in progress].
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.
Patients were randomized to receive the PEG-coated patch (n=15) or standard hemostasis (n=15).
A total of 30 deceased renal transplant donors were enrolled over a 15 month period (17 men and 13 women; mean age = 62.5).
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.
This is a small randomised study of a technical intervention for intra-operative bleeding. The study was very small and therefore I don’t think capable of demonstrating superiority. Patients were randomised prior to transplant surgery, regardless of their requirement for haemostatic adjuncts, and are therefore a dilute population that does not concentrate on those that best benefit from additional haemostatic therapies. Patients in the standard treatment group who required additional haemostatic therapies were also excluded and perhaps should have been included as examples of failure of normal treatment (pressure, ties and clips). The assessment of haemostasis by the operating surgeon is very subjective and not an objective or blinded outcome. The study showed no significant difference in intra-operative blood loss, drop in haemoglobin or requirement for transfusion. No firm conclusions can be drawn from this pilot study and a large trial comparing this product to other haemostatic agents is what is required to follow on from this.
ClinicalTrials.gov - NCT0263367