For patients

The aim of the PROPHESY-2 trial is to determine whether prothrombin complex concentrate (PCC) reduces organ failure, infection or death in comparison to fresh frozen plasma (FFP) in the treatment of people who develop bleeding after cardiac surgery.

Bleeding during or following cardiac surgery can increase the risk of complications like organ failure, infections or death.

Currently, bleeding is treated with transfusion of fresh frozen plasma (FFP), part of donated blood that contains proteins essential for blood clotting. An alternative to FFP is prothrombin complex concentrate (PCC). PCC may have advantages over FFP because it contains higher concentrations of clotting proteins in a smaller volume and does not require thawing like FFP. However, it is thought PCC may increase the risk of developing blood clots (i.e. stroke) by making the blood clot too quickly, although there have been no studies to prove this so far.

To date there have been no studies that have compared FFP and PCC in the treatment of patients who are bleeding following cardiac surgery, so we do not know which treatment is best. If you consent to take part in the PROPHESY-2 trial and you develop bleeding during or up to 24 hours after your heart surgery, you will be randomly allocated to receive FFP or PCC to treat the bleeding. The trial is “open label”, which means both you and your doctor will know which treatment you are given.

If you are randomised, you will be followed up for 90 days following your surgery. This will include completing questionnaires about your post-surgery progress and health.

If you have any questions for the researchers or would like any further information, you can get in touch with the research team by emailing Prophesy2Trial@nhsbt.nhs.uk