PROPHESY-2


PROthrombin complex concentrate versus fresh frozen Plasma for bleeding in adults undergoing HEart SurgerY (PROPHESY-2 trial).

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Summary

The PROPHESY-2 trial is assessing whether prothrombin complex concentrate (PCC) is superior to fresh frozen plasma (FFP) in the treatment of adult patients who are actively bleeding within 24 hours of their cardiac surgery.

Severe bleeding after cardiac surgery occurs in over 10,000 people every year in the UK. It increases the risk of complications such as organ failure, infections or death. Currently, severe bleeding is treated with transfusion of FFP, which contains proteins essential to blood clotting.

An alternative treatment to FFP is 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.

The PROPHESY-2 trial will recruit 496 participants; each will be randomly assigned treatment with FFP or PCC. We will assess if PCC is better than FFP in reducing the rate of organ injury, infection and death in the 90 days following surgery.

For investigators

Aims, eligibility criteria, outcomes and resources

About criteria and resources

For patients

Find out more about what it means to take part

What the study involves

Meet the team

Details about our study staff and contacts

About the team

Sponsor

Queen Mary University of London

Funder

National Institute for Health and Care Research

Trial management

NHSBT Clinical Trials Unit

Disclaimer: This study/project is funded by the NIHR [Health Technology Assessment programme (NIHR152151)]. The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.