British researchers have launched a major trial to see if a concentrated form of pooled plasma will improve outcomes for patients suffering bleeding after heart surgery.
The project, known as Prophesy-2, will directly compare Prothrombin Complex Concentrate (PPC) with fresh frozen plasma (FFP).
PPC is given in smaller doses than FFP, and although this is believed to reduce side effects, the researchers say there have been no large, randomised studies that compare the two treatments.
The project is being run by NHS Blood and Transplant and Queen Mary, University of London. NHS Blood and Transplant currently supplies more than 30,000 doses of FFP a year to treat bleeds from heart surgery.
The first three sites involved in the trial are Derriford Hospital, Plymouth, Southampton General and St Bartholomew’s, London. The project will eventually involve at least 20 centres and is due to recruit 496 patients.
Lead investigator Professor Laura Green, Professor of haemostasis and transfusion medicine at Queen Mary, said PCC use is increasing in the UK.
Professor Green said: “FFP saves lives but it also has side-effects including allergic reactions and transmission of infection. In heart surgery patients there are added risks, due to how weak the heart usually is.
“Prothrombin Complex Concentrate may have advantages over FFP, because it contains higher concentrations of clotting proteins in a smaller volume, and it does not require thawing like FFP. PCC may stop bleeding faster and lead to fewer complications. However, there is a worry that PCC can also increase the risks of developing blood clots by making the blood clot too quickly.
“It is important to conduct a clinical trial to compare the two treatments. No previous trial has compared these two treatments in cardiac surgery. So, we’re excited that the first three sites have opened and the first patient has been randomised.
“We look forwards to working with more centres in England and Wales and we hope the results will inform an important area clinical practice, helping save more lives.”
Source: NHS Blood and Transplant
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