A multicenter, prospective, randomized trial evaluating a new hemostatic agent for spinal surgery

Study Design. A prospective, randomized trial comparing Proceed(TM), a gela tin-based hemostatic sealant (treatment), with Gelfoam-thrombin (control) i n stopping intraoperative bleeding during spinal surgery. Objectives. To determine the effectiveness and safety of Proceed. Summary of Background Data. Proceed has been tested in animal models to det ermine its safety and effectiveness as a hemostatic agent. The current stud y was conducted under a Food and Drug Administration-approved Investigation al Device Exemption to evaluate the effectiveness and safety of Proceed in humans. Methods. For this study, 127 patients undergoing spinal surgery were random ized into either the treatment or control group after standard surgical mea ns 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 applicati on was considered successful if the bleeding stopped within 10 minutes. Fol low-up evaluation was performed at 12 to 36 hours, then at 6 to 8 weeks aft er surgery. Results. Proceed stopped bleeding in 98% of the patients (first bleeding si te 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 . Conclusions. A significantly larger number of bleeding sites had achieved h emostasis with Proceed than with Gelfoam-thrombin at 1, 2, and 3 minutes af ter application. Proceed was as safe as Gelfoam-thrombin when used for hemo stasis during spinal surgery procedures.