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
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
- 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.