Role of Fibrinogen Concentrates in Cardiac Surgery Patients

• Research type

  Research Study

• Full title

  Randomised Placebo Controlled Trial of the use of Fibrinogen Concentrate in Adult Patients Undergoing Cardiac Surgery Using Cardiopulmonary Bypass at High Risk of Receiving an Allogeneic Transfusion

• IRAS ID

  43925

• Contact name

  Ravi Gill

• Eudract number

  2010-020187-38

• ISRCTN Number

  N/A

• Research summary

  Bleeding after cardiac surgery is a common problem that frequently requires transfusion of donated blood and blood coagulation products. The administration of low volume coagulation concentrates as an alternative to the transfusion of other blood coagulation products for treating the bleeding patient after complex cardiac surgery is now an option. There is evidence in the transfusion and cardiac surgery literature that fibrinogen may play an important role in haemostasis. One previous trial has shown that in one specific kind of cardiac surgery fibrinogen concentrate reduced transfusion requirement. The administration of fibrinogen concentrate may reduce transfusion requirements in other kinds of complex cardiac surgery. A major advantage of the use of fibrinogen concentrate is the potential lack of excessive clotting risk when compared to other coagulation agents. We will study the potential benefit of the routine administration of fibrinogen concentrate to patients who are at high risk of needing a transfusion after complex heart surgery. The study will involve randomising patients to receive either fibrinogen concentrate or placebo and then observing the requirement for transfusion after trial product administration.

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  10/H1002/25

• Date of REC Opinion

  28 Jun 2010

• REC opinion

  Further Information Favourable Opinion