PROPHESY-2

• Research type

  Research Study

• Full title

  PROthrombin complex concentrate versus fresh frozen Plasma for bleeding in adults undergoing HEart SurgerY (PROPHESY-2 trial): a phase III, randomised control trial

• IRAS ID

  1009308

• Contact name

  Laura Green

• Contact email

  laura.green@qmul.ac.uk

• Sponsor organisation

  Queen Mary University of London

• ISRCTN Number

  ISRCTN92114384

• Research summary

  Every year in the UK, severe bleeding occurs in over 10,000 people having cardiac surgery. Severe bleeding increases the risks of complications like organ failure and infections, or death. Stopping bleeding quickly could reduce these risks and improve outcomes. Currently, severe bleeding is stopped by transfusion of fresh frozen plasma (FFP), part of donated blood that contains essential proteins for blood clotting.
  PROPHESY-2 aims to determine whether a blood product called prothrombin complex concentrate (PCC) is a superior treatment to a blood product called FFP for adult patients who are actively bleeding within 24 hours of cardiac surgery. Potentially eligible patients will be consented and screened prior to their cardiac surgery, and if they go on to develop bleeding during or within 24 hours of surgery, they will be randomised to receive either PCC or FFP. A total of 496 participants will be randomised (248 per group). Participants will be followed up for 90 days (+/- 7 days) post-surgery and will complete a series of questionnaires relating to their general health, the specific disease that caused them to undergo heart surgery, and the healthcare costs associated with their recovery

• REC name

  London - Fulham Research Ethics Committee

• REC reference

  24/LO/0133

• Date of REC Opinion

  15 Apr 2024

• REC opinion

  Further Information Favourable Opinion