title: 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.
abstract: 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 10/32 (31.3%) [Corrected] subjects in the SoC group achieved hemostasis without needing re-treatment (P < 0.0001). Compared to the SoC group, the FP group showed better hemostasis at 10 min post-randomization [58/59 (98.3 %) vs. 28/32 (87.5 %); P = 0.01], lower mean time to hemostasis (6.1 ± 13.5 vs. 17.8 ± 32.0 min), and a less frequent need for re-treatment (5.1 vs. 53.1 %). The triangular test for binary response demonstrated the FP to be superior to SoC (95 % CI 1.474-3.290; P < 0.0001). Safety profiles in both groups were similar to those typically observed after long-duration surgery.
  
  
  CONCLUSIONS
  The FP is safe and superior to SoC for controlling challenging severe soft-tissue bleeding encountered during intra-abdominal and thoracic surgical procedures.
authors.affiliation: Department of Surgery, Auckland City Hospital, Grafton, New Zealand. jonathan.koea@waitematadhb.govt.nz.|Department of Surgery, North Shore Hospital, Private Bag 93505, Auckland, 0620, New Zealand. jonathan.koea@waitematadhb.govt.nz.
authors.forename: Jonathan
authors.initials: J
authors.lastname: Koea
authors.affiliation: Addenbrooke's Hospital, Cambridge, UK.
authors.forename: Peter
authors.initials: P
authors.lastname: Baldwin
authors.affiliation: Ethicon, Inc., Somerville, NJ, USA.
authors.forename: Jessica
authors.initials: J
authors.lastname: Shen
authors.affiliation: Ethicon, Inc., Somerville, NJ, USA.
authors.forename: B
authors.initials: B
authors.lastname: Patel
authors.affiliation: Ethicon, Inc., Somerville, NJ, USA.
authors.forename: Jonathan
authors.initials: J
authors.lastname: Batiller
authors.affiliation: Ethicon, Inc., Somerville, NJ, USA.
authors.forename: Axel
authors.initials: A
authors.lastname: Arnaud
authors.affiliation: Ethicon, Inc., Somerville, NJ, USA.
authors.forename: James
authors.initials: J
authors.lastname: Hart
authors.affiliation: Ethicon, Inc., Somerville, NJ, USA.
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Hammond
authors.affiliation: Weill Cornell Medical College of Cornell University, Houston, TX, USA.
authors.forename: Craig
authors.initials: C
authors.lastname: Fischer
authors.affiliation: Royal Infirmary of Edinburgh, Edinburgh, UK.
authors.forename: O
authors.initials: O
authors.lastname: James Garden
mesh_terms: D000005:Abdomen / Q000601:surgery; D000328:Adult; D000369:Aged, 80 and over; D005260:Female; D015718:Fibrin Tissue Adhesive / Q000009:adverse effects*; D006488:Hemostasis, Surgical / Q000009:adverse effects*; D006801:Humans; D008297:Male; D008875:Middle Aged; D061214:Patient Safety; D010388:Pelvis / Q000601:surgery; D012187:Retroperitoneal Space / Q000601:surgery; D019616:Thoracic Surgical Procedures; D016896:Treatment Outcome
chemical_list: D015718:Fibrin Tissue Adhesive