About the trial

More information about why the study is needed and the potential benefits it may bring.

PROPHESY-2 is a randomised, pragmatic, multi-centre trial of prothrombin complex concentrate (PCC) versus fresh frozen plasma (FFP) in the treatment of adult patients who are actively bleeding within 24 hours of their cardiac surgery. FFP is the existing standard of care for treatment of bleeding in cardiac surgery, although many cardiac centres in the UK use PCC as part of their treatment protocol. PROPHESY-2 will compare the safety and clinical and cost effectiveness of PCC versus FFP in patients who bleed during or following cardiac surgery.

Potentially eligible patients will be consented up to 90 days prior to their cardiac surgery. Approximately 30 % of patients will develop bleeding during or after their heart surgery, so approximately only 30 % of patients who provide consent to take part in this trial will receive the trial treatment.

If a patient bleeds within 24 hours of surgery and the surgical/clinical team requests FFP for treatment, the patient will be randomised to receive either FFP or PCC. Due to physical differences in the two treatments, it is not possible for the intervention to be blinded. However, the surgical/clinical team will only know which arm the participant has been randomised to after they have requested FFP.

Randomised participants will be followed up for 90 days (approximately three months) following their heart surgery. The primary objective of the trial is to determine if treatment of bleeding with PCC in adult patients who are actively bleeding within 24 hours of the start of their cardiac surgery is superior to FFP with respect to mortality, organ failure or infection, up to and including 90 days from randomisation.

The trial will randomise a total for 496 participants (248 per trial arm).