A Phase III Randomized, Controlled, Superiority Study Evaluating EVARREST Fibrin Sealant Patch Versus Standard of Care Treatment in Controlling Parenchymal Bleeding During Hepatic Surgery

Trial Profile

A Phase III Randomized, Controlled, Superiority Study Evaluating EVARREST Fibrin Sealant Patch Versus Standard of Care Treatment in Controlling Parenchymal Bleeding During Hepatic Surgery

Completed
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
  • Most Recent Events

    • 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.
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