title: A multicentre, prospective, randomized, controlled trial comparing EVARREST™ fibrin sealant patch to standard of care in controlling bleeding following elective hepatectomy: anatomic versus non-anatomic resection.
abstract: BACKGROUND
  This multicentre, randomized clinical trial assessed the safety and effectiveness of the EVARREST™ Fibrin Sealant Patch (FP) in treating parenchymal bleeding following anatomic and non-anatomic liver resections.
  
  
  METHODS
  One hundred and two patients were stratified according to the type of hepatic resection (anatomic/non-anatomic), and randomized (1:1) after identification of an appropriate bleeding site, to FP vs Standard of Care (SoC, manual compression ± topical haemostat). The primary endpoint was haemostasis at 4 min from bleeding site identification with no re-bleeding requiring re-treatment.
  
  
  RESULTS
  The FP was superior in achieving haemostasis at 4 min (96%, 48/50) to SoC (46%, 24/52; p < 0.001). Stratification for resection type showed treatment differences for primary endpoint for anatomic (24/25 FP vs 13/23 SoC; p = 0.001) and non-anatomic liver resections (24/25FP vs 11/29 SoC; p < 0.001). Adverse events related to the study procedure were reported in 40/50 patients (80%) in the FP group and 43/52 patients (83%) in the SoC group. One (2%) adverse event (infected intra-abdominal fluid collection) was possibly related to study treatment.
  
  
  CONCLUSIONS
  This clinical trial confirms that the FP is safe and highly effective in controlling parenchymal bleeding following hepatectomy regardless of the type of resection. ClinicalTrials.gov NCT01993888.
authors.affiliation: The Department of Surgery, Auckland City Hospital, Auckland, New Zealand. Electronic address: jonathan.koea@waitematadhb.govt.nz.
authors.forename: Jonathan B
authors.initials: JB
authors.lastname: Koea
authors.affiliation: Ethicon Inc, Somerville, NJ, United States.
authors.forename: Jonathan
authors.initials: J
authors.lastname: Batiller
authors.affiliation: Ethicon Inc, Somerville, NJ, United States.
authors.forename: Nicolas
authors.initials: N
authors.lastname: Aguirre
authors.affiliation: Ethicon Inc, Somerville, NJ, United States.
authors.forename: Jessica
authors.initials: J
authors.lastname: Shen
authors.affiliation: Ethicon Inc, Somerville, NJ, United States.
authors.forename: Richard
authors.initials: R
authors.lastname: Kocharian
authors.affiliation: Washington University School of Medicine, St. Louis, MO, United States.
authors.forename: Grant
authors.initials: G
authors.lastname: Bochicchio
authors.affiliation: Royal Infirmary of Edinburgh, United Kingdom.
authors.forename: O James
authors.initials: OJ
authors.lastname: Garden
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001315:Australia; D001803:Blood Transfusion; D017558:Elective Surgical Procedures; D005260:Female; D015718:Fibrin Tissue Adhesive / Q000009:adverse effects / Q000627:therapeutic use*; D006489:Hemostatic Techniques / Q000009:adverse effects; D006490:Hemostatics / Q000009:adverse effects / Q000627:therapeutic use*; D006498:Hepatectomy / Q000009:adverse effects*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009520:New Zealand; D019106:Postoperative Hemorrhage / Q000209:etiology / Q000517:prevention & control*; D011446:Prospective Studies; D013997:Time Factors; D014014:Tissue Adhesives / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D006113:United Kingdom; D014481:United States; D055815:Young Adult
chemical_list: D015718:Fibrin Tissue Adhesive; D006490:Hemostatics; D014014:Tissue Adhesives