Controlled clinical trial of a novel hemostatic agent in cardiac surgery

Background:. We performed a prospective randomized trial to compare FloSeal Matrix (Fusion Medical Technologies, Inc, Mountain View, CA), a gelatin-ba sed hemostatic sealant, with Gelfoam-Thrombin (Gelfoam, Pharmacia and Upjoh n, Kalamazoo, MI; Thrombin, Gentrac Inc, Middeton, WI) (control group) to c ontrol perioperative bleeding. Methods:. A total of 93 patients undergoing cardiac operations were randomi zed into the FloSeal or control group after standard surgical means to cont rol bleeding had failed. The bleeding site was evaluated at 1, 2, 3, 6, aci d 10 minutes after applying the hemostatic agent. If bleeding stopped withi n 10 minutes, the application was considered to be successful. In the case of a failure, the surgeon could use any means preferred (except FloSeal) to achieve hemostasis. All bleeding sites in a patient were treated with the hemostatic agent to which the patient was randomized. Follow-up evaluation was performed at 12 to 36 hours and 6 to 8 weeks after operation. Results:. FloSeal stopped bleeding in 94% of the patients (first bleeding s ite only) within 10 minutes, compared to 60% in the control group (p = 0.00 1). At 3 minutes, successful hemostasis was achieved in 72% of the FloSeal group compared with 23% in the control group (p = 0.0001). There was no dif ference in the adverse event profile between the two groups. Conclusions:. FloSeal Matrix demonstrated efficacy superior to that of Gelf oam-Thrombin and had a safety profile similar to that of Gelfoam-Thrombin w hen used as a topical hemostatic agent during cardiac surgery procedures. (C) 2000 by The Society of Thoracic Surgeons.