Preoperative treatment of a low haemoglobin in cardiac surgery

• Research type

  Research Study

• Full title

  Preoperative treatment of a low haemoglobin in cardiac surgery: pragmatic open-label randomised controlled trial to compare treatment using intravenous iron plus darbepoetin versus standard care

• IRAS ID

  29143

• Contact name

  Robert Kong

• Eudract number

  2011-003695-36

• ISRCTN Number

  n/a

• Research summary

  About a third of patients having heart surgery will have a low haemoglobin level before surgery. Haemoglobin is the blood component that carries oxygen. "Anaemia" or a "low blood count" means an abnormally low haemoglobin level. Blood loss during and after heart surgery will cause the haemoglobin level to fall. So patients with low haemoglobin before surgery will have an even lower level after surgery. This can become dangerous because there could be insufficient oxygen in the body's a result. Very low haemoglobin after surgery is treated by blood transfusion. However, blood transfusion is also linked to higher risks of complications and death after surgery. In other words, blood transfusion is best avoided when possible. Research has shown that the lower the haemoglobin level before surgery, the higher the risk of blood transfusion and complications. If the haemoglobin can be increased before surgery, both blood transfusion and complication rates might be reduced. A frequent cause of low haemoglobin is iron deficiency. This is usually treated by iron tablets. However, this can take many months to work and could delay surgery. An alternative method is to give iron by injection and also speed up the haemoglobin increase using a drug called darbepoetin. This approach has never been tested. In this study, we are trying to find out if this alternative approach will be more effective than iron tablets at reducing blood transfusion and complications after surgery. Patients scheduled to undergo heart surgery at the Sussex Cardiac Centre and have low haemoglobin before surgery will be offered the chance to take part. Participants will receive iron tablets or the alternative treatment in a randomised fashion. The study will be funded by the Royal College of Surgeons of England, The Sussex Heart Charity and Pharmacos (Denmark), the company that makes the iron injection.

• REC name

  London - Harrow Research Ethics Committee

• REC reference

  11/LO/1310

• Date of REC Opinion

  11 Jan 2012

• REC opinion

  Further Information Favourable Opinion