Clinical evaluation of the use of novel and completely autologous fibrin glue during surgical procedures: Prospective open multicenter trial of the CryoSeal FS System

Abstract

Objective: Evaluate the clinical efficacy and safety of autologous fibrin glue (AFG) prepared by CryoSeal®. Background: Control of oozing during surgery remains an important task for surgeons. Although commercial adhesives and hospital made fibrin glue are often used to control oozing, the risk of pathogen transmission and allergic reaction cannot be completely avoided. Methods: A multicenter, open-label, non-randomized study was conducted with 74 patients undergoing surgery with preoperative autologous blood transfusion. CryoSeal® was used to prepare autologous cryoprecipitate and thrombin from patient blood. Hemostatic effects were assessed in 62 of 74 patients. Results: On average, 263.8±26.7ml of plasma was collected, and 5.3±1.2ml of both cryoprecipitate and thrombin were prepared. Median in vitro clotting time for AFG was 4.1 seconds (range, 1.3-195.2 seconds). The hemostatic effect against oozing was effective in 54 of 62 patients (87%). The effective rate in patients with thrombin activity ≥20U/ml was 96% (46 of 48 patients), which was significantly higher than 54% (7 of 13) in patients with thrombin activity <20U/ml(p<0.001, Fisher's test). Complications attributable to the use of AFG were not observed. Conclusions: AFG produced by CryoSeal® was prepared in a short time and clinically effective in stopping oozing. Our results show that AFG could be used for adjunct hemostasis as well as commercial adhesives and hospital made fibrin glue.