The Severe Soft Tissue Bleeding Study (final: 15th July 2008)

• Research type

  Research Study

• Full title

  A Phase III Randomised, Controlled, Superiority Study Evaluating the Fibrin Pad Versus Standard of Care Treatment in Controlling Severe Soft Tissue Bleeding During Abdominal, Retroperitoneal, Pelvic, and Thoracic Surgery

• IRAS ID

  7429

• Sponsor organisation

  OMRIX Biopharmaceuticals Ltd.

• Eudract number

  2008-004835-39

• ISRCTN Number

  n.a

• Clinicaltrials.gov Identifier

  n.a

• Research summary

  A phase III study investigatingthe use of Fibrin Pad to control severe soft tissue bleeding during openabdominal, retroperitoneal, pelvic and thoracic surgery. If the surgeonencounters a challenging severe target bleeding site during the surgicalprocedure, the patient will be randomised to receive either the Fibrin Pad orStandard of Care treatment.

• REC name

  East of England - Cambridge South Research Ethics Committee

• REC reference

  08/H0305/62

• Date of REC Opinion

  13 Nov 2008

• REC opinion

  Further Information Favourable Opinion