A Prospective, Randomised, Controlled, Study Evaluating the Safety and Effectiveness of EVARREST Fibrin Pad in Controlling Mild or Moderate Soft Tissue Bleeding During Abdominal, Retroperitoneal, Pelvic and (non-cardiac) Thoracic Surgery in Paediatric Patients

Trial Profile

A Prospective, Randomised, Controlled, Study Evaluating the Safety and Effectiveness of EVARREST Fibrin Pad in Controlling Mild or Moderate Soft Tissue Bleeding During Abdominal, Retroperitoneal, Pelvic and (non-cardiac) Thoracic Surgery in Paediatric Patients

Recruiting
Phase of Trial: Phase III

Latest Information Update: 19 Jul 2016

At a glance

  • Drugs Fibrin (Primary)
  • Indications Surgical blood loss
  • Focus Adverse reactions; Therapeutic Use
  • Sponsors Ethicon
  • Most Recent Events

    • 14 Jul 2016 Planned End Date changed from 1 Nov 2017 to 31 Dec 2018.
    • 16 Jun 2016 Planned End Date changed from 1 Nov 2018 to 1 Nov 2017.
    • 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.
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