REPLACE - FCH vs. placebo in cardiovascular surgery

• Research type

  Research Study

• Full title

  REPLACE (Randomised evaluation of fibrinogen versus placebo in complex cardiovascular surgery): a prospective, multinational, multicenter, randomised, double-blind, placebo-controlled, phase III study for the use of Fibrinogen Concentrate (Human) (FCH) in complex cardiovascular surgery

• IRAS ID

  86444

• Contact name

  Ravijit Gill

• Sponsor organisation

  CSL Behring

• Eudract number

  2011-002685-20

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Cardiac (heart) surgery can frequently be complicated by excessive bleeding around the time of operation, most often due to failure in stopping the bleeding by surgical methods and/or problems relating to clotting. There is a high potential for bleeding during repair of an abnormal widening of a portion of the body??s largest artery in the chest (thoracic aortic aneurysm or thoracoabdominal aortic aneurysm), due to the combination of methods used ?? temporarily lowering the body temperature to lower-than-normal (hypothermia), lengthy use of a heart-lung machine and an artificial vessel graft. The circulation of blood outside of the body technique (e.g. using heart-lung machine) employed during heart surgery is linked to temporary disruption of the body??s systems that stop or slow down blood flow (haemostatic system) and break down blood clots (fibrinolytic system). Current therapies consist mainly of the use of blood products donated by people other than the patient, including platelets (involved in clotting process) and fresh frozen plasma (the liquid part of blood). However, each of these products can be associated with risks related to living organisms causing disease, substances triggering the body??s immune system to produce antibodies against it (antigens), antibody transmission and host response. The study drug, Fibrinogen Concentrate (Human) (FCH), is obtained from a protein (called fibrinogen) in human plasma. It is currently approved for the treatment of fibrinogen deficiency under trade name RiaSTAP© in 14 countries and under trade name Haemocomplettan© P in 15 countries. There is currently an unmet need for a low-volume, virus in-activated (unable to infect) fibrinogen replacement that allows rapid dosing, provides a reliable quantity of fibrinogen and is readily available for patients with bleeding associated with reduced fibrinogen level or function. This is a multicentre study which will take place in 10-15 centres globally, and approximately 152 participants will be recruited worldwide.

• REC name

  South Central - Hampshire A Research Ethics Committee

• REC reference

  11/SC/0438

• Date of REC Opinion

  18 Nov 2011

• REC opinion

  Further Information Favourable Opinion