The EVARREST® Fibrin Sealant Patch Liver Study

Summary

To evaluate the safety and hemostatic effectiveness of EVARREST® Fibrin Sealant Patch (EVARREST) versus standard of care treatment (SoC) in controlling parenchymal bleeding during hepatic surgery.

Timeline

Start

2013-10

Primary completion

2014-07

Completion

2014-09

Outcome

Met primary endpoint

paper The FP was superior in achieving haemostasis at 4 min (96%, 48/50) to SoC (46%, 24/52; p < 0.001). PMID 27017161 ↗

registry analysis (superiority or other test); EVARREST™ Fibrin Sealant Patch vs Standard of Care (SoC); p <.0001; Chi-squared NCT01993888 ↗

Publications

• Results Koea JB, Batiller J, Aguirre N, Shen J, Kocharian R, Bochicchio G, Garden OJ. 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. HPB (Oxford). 2016 Mar;18(3):221-8. doi: 10.1016/j.hpb.2015.12.006. Epub 2016 Feb 1.
• Corral M, Ferko N, Hollmann S, Hogan A, Jamous N, Batiller J, Shen J. Clinician reported ease of use for a novel fibrin sealant patch for hemostasis: results from four randomized controlled trials. Curr Med Res Opin. 2016;32(2):367-75. doi: 10.1185/03007995.2015.1128405. Epub 2015 Dec 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	EVARREST® Fibrin Sealant Patch	Protein / enzyme biologic	—	—

Indications