A Single-blinded, Randomized, Controlled, Comparative Phase III Study Evaluating the Safety and Effectiveness of EVARREST Fibrin Sealant Patch as an Adjunct to Hemostasis During Cardiovascular Surgery

Trial Profile

A Single-blinded, Randomized, Controlled, Comparative Phase III Study Evaluating the Safety and Effectiveness of EVARREST Fibrin Sealant Patch as an Adjunct to Hemostasis During Cardiovascular Surgery

Completed
Phase of Trial: Phase III

Latest Information Update: 18 Aug 2017

At a glance

  • Drugs Fibrin (Primary) ; Haemostasis stimulants
  • Indications Haemorrhage
  • Focus Registrational; Therapeutic Use
  • 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.
    • 05 Mar 2016 Results published in Ethicon media release.
    • 20 Oct 2015 Status changed from recruiting to completed as reported by ClinicalTrials.gov record.
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