Safety and Hemostatic Effectiveness of the Fibrin Pad for Severe Soft-Tissue Bleeding During Abdominal, Retroperitoneal, Pelvic, and Thoracic (Non-cardiac) Surgery: A Randomized, Controlled, Superiority Trial

Background In surgery, rapid hemostasis can be required in various settings and bleeding intensities to minimize complications related to blood loss. While effective hemostats are available for mild-to-moderate surgical bleeding, few are effective against challenging severe hemorrhage. We report the effectiveness and safety of the fibrin pad (FP), a novel combination hemostat (device/human biologic), in controlling severe soft-tissue bleeding as compared to the standard of care (SoC). Methods This randomized, controlled, superiority study enrolled subjects ≥18 years, requiring elective abdominal, retroperitoneal, pelvic, or thoracic (non-cardiac) surgery. A severe target bleeding site (TBS) was identified intra-operatively following which, subjects were randomized to the FP or the SoC group. Hemostatic status was observed at 4 min (primary endpoint) and 10 min post-randomization. Safety variables included TBS-related bleeding and thrombotic events. Results At 4 min post-randomization, 50/59 (84.7 %) subjects in the FP group and 16/32 (50 %) subjects in the SoC group achieved hemostasis without needing re-treatment ( P