Prospective randomized study evaluating the effects of PerClot® (Polysaccharide Hemostatic System) application in patients with high bleeding risk undergoing cardiac rhythm device implantation. (1st December 2017) - Tscholl, Verena
Abstract: Background: Thus far, the topic hemostatic agent PerClot® is used for surgical procedures. Data about the use of PerClot® for cardiac-rhythm-devices (CRD) implantation are missing. The aim of this study was to evaluate the safety and efficacy of PerClot® in patients with high bleeding risk. Methods and results: In this prospective randomized study we planned to include 150 patients admitted for CRD-Implantation receiving anticoagulation and/or dual-antiplatelet-therapy. Participants were randomized to receive PerClot® versus standard-of-care. The primary endpoint was the incidence of pocket hematoma. Safety endpoint was pocket infection. After a planned safety-interim-analysis the study was terminated early because of safety concerns. 51 patients were included. The two groups were comparable with regard to age (73 ± 11 years vs. 74 ± 10 years; p = 0.71), CHA2 DS2 VASc (3.6 ± 1.5 vs. 4.0 ± 1.5; p = 0.27) and HASBLED-Score (2.4 ± 1.1 vs. 2.5 ± 1.0; p = 0.98), CRD or procedure type, anticoagulant or anti-platelet therapy. The use of PerClot® resulted in a higher incidence of postoperative fever (7 (28%) vs. 0 (0%); p = 0.004), higher C-Reactive Protein (66.1 ± 50.5 mg/l vs. 25.9 ± 22.5 mg/l; p = 0.002); and higher postoperative white blood cell count (13.5 ± 4.3/nl vs. 8.8 ± 2.6/nl; p < 0.001). Hematoma formation did not differ significantly (p = 0.14). Reoperation was not necessary in any patient. Conclusion: This first randomized controlled study for the topical use of the hemostatic agent PerClot® in CRD implantation was terminated early by the safety monitoring board because of an augmented rate of fever and inflammatory markers in the PerClot® group. The addition of PerClot® does not suggest a benefit with regard to the frequency of pocket hematoma.