The Safety of a Combination Hemostatic Powder During Spine Surgical Procedures:

Study Design: This was a multicenter, prospective, randomized, single-blinded clinical trial. Objective: The study evaluated the safety of a combination hemostat powder (CHP) (HEMOBLAST Bellows) for achieving hemostasis in open, elective, spine procedures. Summary of Background Data: The literature on the safety of hemostatic agents documents complications secondary to their use in spine procedures, including cord compression, arachnoiditis, and epidural fibrosis. However, the safety of CHP in spinal surgery is unknown. Materials and Methods: Adult subjects (n=60), at 5 centers across the United States over a 31-month period, were randomized (2:1) to receive either CHP (n=40) or the control agent of absorbable gelatin sponge, USP soaked in recombinant thrombin (G+T) (n=20). The study was executed in two phases using mandatory magnetic resonance imaging with gadolinium (MRI+Gd) in stage 1 and conditional MRI+Gd in stage 2. The primary endpoint was the incidence of unanticipated adverse device effects (UADEs), including epidural fibrosis and arachnoiditis, at 12 weeks. The secondary endpoint was the proportion of adverse events (AEs) for CHP compared with G+T subjects. Efficacy endpoints, defined as time to hemostasis (TTH), were exploratory. Results: The primary endpoint was achieved with no UADEs observed. The secondary endpoint was met as CHP subjects had 80 AEs (67.5%) and G+T had 41 AEs (65.0%) ( P >0.9999). One CHP subject had deep venous thrombosis (DVT) (probability 2.5%, 95% CI: 0.6%, 13.2%), and two had pulmonary emboli (PE) (probability 5%, 95% CI: 1.6%, 16.9%), with neither observed in G+T subjects. Time to hemostasis within 3 minutes was 84.4% for CHP subjects versus 55.0% for G+T subjects ( P ≤0.03); familywise type I error rate for exploratory endpoints was uncontrolled. Conclusion: CHP met the prespecified primary and secondary safety endpoints. A time to hemostasis advantage for CHP at 3 minutes was observed. Level of Evidence: Level 1.