Multi-center, phase III randomized, controlled, study evaluating the superiority of fibrin pad versus standard of care treatment in controlling bleeding during elective hepatic surgery

Aims: Hemostasis following liver resection may be problematic due to anatomic, physiologic or surgical factors that contribute to the bleeding challenge. EVARREST®; (Johnson & Johnson) is a Fibrin pad (FP) hemostat designed to be effective in a variety of tissues and across multiple bleeding challenges and intensities. This is a clinical evaluation of the hemostat's safety and effectiveness involving institutions in the USA, UK, Australia and New Zealand. Methods: This randomized trial enrolled 102 subjects of 211 subjects screened in 16 institutions. Subjects were stratified according to the type of hepatic resection (anatomic/non-anatomic), and randomized 1:1 after identification of an appropriate bleeding site, FP versus Standard of Care (SoC), which included manual compression with or without the use of an approved topical absorbable hemostat. The primary endpoint was hemostasis at 4 minutes from identification of the bleeding site with no re-bleeding requiring re-treatment prior to abdominal closure. All subjects were followed for 60 days post-operatively. Results: The intent to treat analysis showed a significant treatment advantage for FP and this was most marked when used in non-anatomic resections (table). Adverse events related to the study procedure was observed in 40/50 subjects (80%) in the FP group and 43/52 subjects (82.7%) in the SoC group. Conclusions: FP is safe and effective when used as an adjunct to hemostasis during hepatic surgery regardless of the type of resection, or the condition of the parenchymal tissue. There was no difference in safety profile between FP or SoC groups.