Which product saves more lives when someone bleeds after heart surgery – new trial recruits first patients

A NEW trial led by NHS Blood and Transplant and Queen Mary University of London has started investigating whether giving a clotting factor to people who bleed after heart surgery will help save and improve more lives.

Major bleeding is a feared complication after surgery. There are around 33,000 open heart surgeries in the UK each year. Around a third are followed by clinically significant bleeds, with increased risk of infection, organ damage and death.

Currently, severe bleeding is stopped by transfusion of Fresh Frozen Plasma (FFP), which is collected from blood donations. FFP contains proteins which help blood to clot. But it can cause transfusion side effects such as a transfusion related acute lung injury.

The new Prophesy-2 trial is testing if giving people Prothrombin Complex Concentrate (PPC) – a concentrated form of pooled plasma – will have better outcomes. PPC is richer in the proteins which help the blood to clot. This means it can be given in smaller doses, which reduces transfusion side effects. However, no large studies have compared PCC with FFP.

Prophesy-2 will see whether PPC has better outcomes than FFP for a range of measures such as mortality, infection, and organ injury. It will also assess which treatment is more cost effective. The trial will randomise 496 participants over two years.

The trial is being run by NHS Blood and Transplant and Queen Mary University of London. It is funded with a grant from the National Institute of Health Care Research’s Health Technology Assessment programme. It is managed by NHSBT’s Clinical Trials Unit.

The first three sites have opened this month – Derriford Hospital in Plymouth, Southampton General, and St Bartholomew’s in London – and the first patient has just been randomised.

Trial chief investigator Professor Laura Green is a Principal Investigator at NHS Blood and Transplant and a Professor of Haemostasis and Transfusion Medicine at Queen Mary University of London. She said: “Bleeding during or following cardiac surgery can increase the risk of complications like organ failure, infections or death.

“Of the 250,000 Fresh Frozen Plasma (FFP) doses that NHS Blood and Transplant sends to hospitals every year, more than 30,000 (12%) are used to treat bleeds from heart surgery. 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 (PCC) 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.

“PCC use is increasing in the UK, so 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.”