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The William Harvey Research Institute - Barts and The London

PROPHESY

A pragmatic pilot randomised controlled trial of Prothrombin Complex Concentrate (PCC) versus Fresh Frozen Plasma (FFP) in adult patients who are undergoing Heart Surgery.  

Trial Objective: To determine the proportion of participants who consent to the study and receive the intervention. Secondary objectives will assess the delivery of different components of the trial, and compare the impact of FFP and PCC on the haemostatic capacity of bleeding patients.
Disease area: Cardiac Surgery
Status: Actively recruiting
Chief Investigator: Dr Laura Green
Principal Investigators: Professor Ben O'Brien, Mr Neil Roberts
Sponsor: Queen Mary University of London
Funder: British Heart Foundation
NCT REF: ClinicalTrials.gov Identifier: NCT03715348

Study summary

There are currently around 30,000 heart surgery procedures performed each year in the UK. Bleeding during heart surgery that requires fresh frozen plasma (FFP) transfusion can occur in up to 30% of cases. 

FFP is the standard treatment in bleeding patients during any surgery, but another product, Prothrombin complex concentrate (PCC) is being used worldwide to help stop bleeding, because it has more concentrated levels of clotting factors than FFP, and therefore it is believed that it may stop the bleeding quicker. However, there have been no studies that have compared the two products in cardiac surgery in patients who are bleeding. 

In this pilot study, subjects will be selected at random to have either FFP or PCC if they bleed during, and within 24 hours of heart surgery. The study is ‘open label’, which means that you and your study doctor will know which product you are given. The choice of treatment will also depend on your study doctor’s clinical decision and your blood clotting results.

We are inviting patients either with planned heart surgery or having emergency heart surgery and who are not receiving vitamin K antagonist agents (e.g. warfarin) to join the study.

Sample size and duration

50 patients, taking place at Barts Trust, London with recruitment over a 15 month period.

Investigators

Professor Ben O’Brien - Co-investigator
Mr Neil Roberts- Co-investigator
Dr Ravi Gill - Co-investigator
Dr Andrew Klein - Co-investigator
Dr Seema Agarwal - Co-investigator
Professor Simon Stanworth - Co-investigator 
Jackie Cooper - CVCTU Senior Statistician
Jane Field - CVCTU Manager
Professor Atholl Johnston - CVCTU Senior Statistician
Dr Vivienne Monk - CVCTU Manager

Enquiries

For further information about the study, please contact a member of the research team:

Tel: +44(0) 20 8957 2756

Funders