A Phase III Randomized, Controlled, Superiority Study Evaluating EVARREST Fibrin Sealant Patch Versus Standard of Care Treatment in Controlling Parenchymal Bleeding During Hepatic Surgery
Phase of Trial: Phase III
Latest Information Update: 24 Mar 2017
At a glance
- Drugs Fibrin (Primary)
- Indications Haemorrhage; Surgical blood loss
- Focus Adverse reactions; Registrational
- Sponsors Ethicon
- 05 Mar 2016 According to Ethicon media release, data from this trial is part of a pending regulatory submission to the U.S. Food and Drug Administration ("FDA") to expand the indication for EVARREST in the United States.
- 20 May 2015 Pooled economic analysis results presented at the 20th Annual International Meeting of the International Society for Pharmacoeconomics and Outcomes Research.
- 19 Oct 2014 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov record.