PROPHESY
Research type
Research Study
Full title
A pragmatic pilot randomised controlled trial of Prothrombin Complex Concentrate (PCC) versus Fresh Frozen Plasma (FFP) in adult patients who are undergoing Heart Surgery
IRAS ID
250632
Contact name
Laura Green
Contact email
Sponsor organisation
Queen Mary University of London
Eudract number
2018-003041-41
Duration of Study in the UK
1 years, 9 months, 2 days
Research summary
There are currently around 30,000 heart surgery procedures performed each year in the UK. Bleeding during heart surgery that requires blood transfusion can occur in 10-30% of cases, and being able to stop it quickly could reduce the risk of complications, and possible death. Knowing the best way to treat bleeding during surgery is difficult, as it is impossible to tell if and how the bleeding will develop at the time of surgery. Fresh frozen plasma (FFP and LG-Octaplas) are the standard treatment in bleeding patients after any surgery, but another product, called Prothrombin Complex concentrate (PCC) is being used worldwide to help stop bleeding, because it is believed that it may stop the bleeding quicker than FFP/LG Octaplas due to having a more concentrated clotting factor levels. However, there have been no randomised control trial that have compared the safety and efficacy of the two products in cardiac surgery in patients who are bleeding, and who are not receiving vitamin K antagonist agents (e.g. warfarin). Prior to such a trial, we propose to perform a pilot study to assess if individual components of a large trial are deliverable.
PROPHESY is a single-centre pilot (open-label,randomised, controlled) trial that will assess if PCC when compared to standard care (FFP or LG Octaplas) in patients who are bleeding (not on warfarin) during cardiac surgery and who require blood transfusion, is a feasible and acceptable intervention.REC name
London - Fulham Research Ethics Committee
REC reference
18/LO/1726
Date of REC Opinion
29 Oct 2018
REC opinion
Favourable Opinion