PROPHESY

Read the papers:

1. Prothrombin complex concentrate vs. fresh frozen plasma in adult patients undergoing heart surgery – a pilot randomised controlled trial (PROPHESY trial)
2. Impact of prothrombin complex concentrate and fresh frozen plasma on correction of haemostatic abnormalities in bleeding patients undergoing cardiac surgery (PROPHESY trial results)
3. A pragmatic pilot phase II randomised controlled trial of prothrombin complex concentrates (PCC) versus fresh frozen plasma (FFP) in adult patients who are undergoing heart surgery (PROPHESY)

Full Title: A pilot study to compare fresh frozen plasma (FFP) and prothrombin complex concentrate (PCC) for the treatment of bleeding in adult patients undergoing cardiac surgery

Short Title: PROPHESY

Sponsor: Queen Mary University of London

Funder: British Heart Foundation

Chief Investigator: Prof Laura Green, Professor of Haemostasis and Transfusion Medicine; Consultant in Haemostasis and Transfusion Medicine, Queen Mary University of London

Co-Investigators: Professor Ben O'Brien, Principal Investigator; Mr Neil Roberts, Principal Investigator; Dr Ravi Gill, Co-Investigator; Dr Andrew Klein, Co-Investigator; Dr Seema Agarwal, Co-Investigator; Professor Simon Stanworth, Co-Investigator

Contact: laura.green27@nhs.net

Registration: https://www.clinicaltrials.gov/study/NCT03715348

Study Design: Pilot randomised, open-label clinical trial

Objectives:

• To determine the proportion of participants who consent to the study and receive the intervention
• To assess the feasibility of delivering the trial components and compare the haemostatic effects of FFP versus PCC in cardiac surgery patients

Number of Participants: 50

Interventions Used: FFP and PCC

Study Duration: 15 months

Location: Barts Health NHS Trust, London

Summary: Each year in the UK, approximately 30,000 heart surgeries are performed, with bleeding requiring fresh frozen plasma (FFP) transfusion occurring in up to 30% of cases. While FFP is the current standard treatment, Prothrombin Complex Concentrate (PCC) is gaining attention internationally as a potentially more effective alternative due to its higher concentration of clotting factors, which may stop bleeding more quickly.

This pilot study evaluated the use of FFP versus PCC in adult patients who experienced bleeding during or within 24 hours of heart surgery. Participants were randomised to receive either FFP or PCC, depending also on clinical judgement and blood clotting test results. The study was open-label, meaning patients and doctors were aware of the treatment administered.

The aim was to assess feasibility—particularly the proportion of participants who consented and received the intervention—and to compare the delivery and haemostatic impact of both treatments. Eligible participants included those undergoing elective or emergency cardiac surgery not on vitamin K antagonists (e.g. warfarin).