The Fibrin Pad Liver study

• Research type

  Research Study

• Full title

  A Phase III Randomised, Controlled, Superiority Study Evaluating the Fibrin Pad Versus Standard of Care Treatment in Controlling Parenchymal Bleeding During Elective Hepatic Surgery.

• IRAS ID

  49660

• Contact name

  James Garden

• Sponsor organisation

  Omrix Biopharmaceuticals Ltd.

• Eudract number

  2010-019427-58

• Clinicaltrials.gov Identifier

  01166243

• Research summary

  A phase III study investigating the use of Fibrin Pad to control bleeding from the liver during elective hepatic surgery. If the surgeon encounters a target bleeding site during the surgical procedure, the patient will be randomised to receive either the Fibrin Pad or Standard of Care treatment.

• REC name

  West of Scotland REC 1

• REC reference

  10/S0703/20

• Date of REC Opinion

  19 May 2010

• REC opinion

  Further Information Favourable Opinion