A Multicenter, Prospective, Randomized Trial Evaluating a New Hemostatic Agent for Spinal Surgery

Abstract

A prospective, randomized trial comparing Proceed™, a gelatin-based hemostatic sealant (treatment), with Gelfoam–thrombin (control) in stopping intraoperative bleeding during spinal surgery. To determine the effectiveness and safety of Proceed. Proceed has been tested in animal models to determine its safety and effectiveness as a hemostatic agent. The current study was conducted under a Food and Drug Administration–approved Investigational Device Exemption to evaluate the effectiveness and safety of Proceed in humans. For this study, 127 patients undergoing spinal surgery were randomized into either the treatment or control group after standard surgical means to control bleeding had failed. The bleeding site was evaluated at 1, 2, 3, 6, and 10 minutes after the hemostatic agent was applied. The application was considered successful if the bleeding stopped within 10 minutes. Follow-up evaluation was performed at 12 to 36 hours, then at 6 to 8 weeks after surgery. Proceed stopped bleeding in 98% of the patients (first bleeding site only) within 10 minutes, as compared with 90% of the control patients (P = 0.001). At 3 minutes, successful hemostasis had been achieved in 97% of the Proceed group, as compared with 71% of the control group (P = 0.0001). There was no difference in the adverse event profile between the two groups. A significantly larger number of bleeding sites had achieved hemostasis with Proceed than with Gelfoam–thrombin at 1, 2, and 3 minutes after application. Proceed was as safe as Gelfoam–thrombin when used for hemostasis during spinal surgery procedures.