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Prospective randomized study evaluating the effects of PerClot® (Polysaccharide Hemostatic System) application in
Verena Tscholl1, Felicitas Spann1, Jane Moses2
1Charité Universitaetsmedizin Berlin, Campus Benjamin Franklin, Department of Cardiology, Berlin, Germany.
Insights
The hemostatic agent PerClot® showed increased fever and inflammatory markers in cardiac-rhythm-device implantations. This study was stopped early, finding no benefit for pocket hematoma reduction with PerClot® use.
Area of Science:
- Cardiology
- Medical Devices
- Surgical Hemostasis
Background:
- PerClot® is a hemostatic agent used in surgery.
- Limited data exists on PerClot® use during cardiac rhythm device (CRD) implantation.
- Patients undergoing CRD implantation often have high bleeding risk.
Purpose of the Study:
- To evaluate the safety and efficacy of PerClot® in CRD implantation.
- To assess PerClot®'s impact on pocket hematoma and infection.
- To compare PerClot® with standard care in high-risk patients.
Main Methods:
- Prospective randomized study.
- Included patients receiving anticoagulation and/or dual-antiplatelet therapy for CRD implantation.
- Randomized to PerClot® or standard-of-care; study terminated early due to safety concerns.
Main Results:
- 51 patients included; study terminated early.
- PerClot® group showed higher postoperative fever (28% vs. 0%), elevated C-Reactive Protein, and increased white blood cell counts.
- No significant difference in hematoma formation (p=0.14); no reoperations needed.
Conclusions:
- Early termination due to safety concerns (fever, inflammation) with PerClot®.
- PerClot® did not demonstrate a benefit in reducing pocket hematoma frequency.
- Topical hemostatic agent PerClot® use in CRD implantation requires caution.
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±11years vs. 74±10years; p=0.71), CHA2DS2VASc (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±50.5mg/l vs. 25.9±22.5mg/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.
