Evidence map›Paper›PMID 41546086›Full record

Trial reportTrials2026

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

Charlie Brown-O'Sullivan, Seema Agarwal, Enoch Akowuah, Emily Arbon, Maisie Gardner, Eleanor Hounslea, Cara Hudson, Andrew Klein, Mahmoud Loubani, Josephine McCullagh and 11 more

Abstract readRandomized Controlled TrialPragmatic Clinical TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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0citing papers in PubMed
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1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

21 authors.

Charlie Brown-O'SullivanNHS Blood and Transplant Clinical Trials Unit, Cambridge, UK. Charlie.brown@nhsbt.nhs.uk.ORCID http://orcid.org/0009-0003-6137-8437
Seema AgarwalManchester University Hospital, Manchester, UK.
Enoch AkowuahNewcastle University, Newcastle, UK.
Emily ArbonNHS Blood and Transplant Clinical Trials Unit, Cambridge, UK.
Maisie GardnerNHS Blood and Transplant Clinical Trials Unit, Cambridge, UK.
Eleanor HounsleaNHS Blood and Transplant Clinical Trials Unit, Cambridge, UK.
Cara HudsonNHS Blood and Transplant Clinical Trials Unit, Cambridge, UK.
Andrew KleinRoyal Papworth Hospital NHS Foundation Trust, Cambridge, UK.
Mahmoud LoubaniHull University Teaching Hospitals, NHS Trust, Cottingham, UK.
Josephine McCullaghNHS Blood and Transplant and Barts Health NHS Trust, London, UK.
Gavin MurphyUniversity of Leicester, Leicester, UK.
Sarah MurrayPatient and Public Representative, London, UK.
Claire RourkeNHS Blood and Transplant Clinical Trials Unit, Cambridge, UK.
Julie SandersKing's College London, London, UK.
Laura SimpsonQueen Mary University of London, London, UK.
Laura SmithNHS Blood and Transplant Clinical Trials Unit, Cambridge, UK.
Simon StanworthNHS Blood and Transplant, Oxford University Hospitals NHS Trust and University of Oxford, Oxford, UK.
Florian TominiQueen Mary University of London, London, UK.
Naomi VidesNHS Blood and Transplant Clinical Trials Unit, Cambridge, UK.
Jessica WorkmanNHS Blood and Transplant Clinical Trials Unit, Cambridge, UK.
Laura GreenNHS Blood and Transplant and Barts Health NHS Trust, London, UK.

Funding

National Institute for Health and Care Research NIHR152151
6 · The paper itself

Abstract

backgroundFresh frozen plasma (FFP) is the standard treatment for severe bleeding following cardiac surgery. Despite increasing use of prothrombin complex concentrate (PCC) for coagulopathic bleeding in preference to FFP in the UK, the evidence comparing FFP versus PCC in this setting is lacking. HYPOTHESIS: In adults who develop severe bleeding, PCC is superior to FFP in reducing a composite of mortality, organ failure, or infection up to 90 days following cardiac surgery, and is more cost-effective.

methodsPhase III pragmatic, multicentre, parallel group, superiority, non-blinded, open-label, two-stage group sequential randomised controlled trial with internal pilot embedded. Participants will be recruited by the research team at up to 20 hospitals in England and Wales. Those who have provided informed consent and who develop bleeding within 24 h of cardiac surgery (elective and urgent procedures) will be randomised to PCC (1500 IU if ≤70 kg or 2000 IU if >70 kg; a maximum of 2 doses) or FFP (4 units if ≤70 kg and 5 units if >70 kg; no maximum dose). Randomisation will be stratified by site and will allocate participants using minimisation, with a 1:1 ratio to receive PCC or FFP. Age (≥70 and <70 years) and planned type of surgery (valve only, major aortic surgery, coronary artery bypass graft + valve, and complex/combined procedure) will be the minimisation factors. The primary outcome is a composite of mortality or new onset of respiratory failure, myocardial injury, renal failure, liver injury, intestinal injury, focal neurological deficit, or infection at 90 days. Secondary outcomes will compare safety (transfusion-related reactions, thrombosis), quality of life, healthcare costs, and cost-effectiveness. A sample size of 496 participants will have a 90% power (with a 5% significance level) to detect a relative risk of 0.7 between the two groups at 90 days. The date of the 1st patient enrolled was 11th February 2025. DISCUSSION: This trial will provide evidence on the clinical/cost-effectiveness of PCC versus FFP in cardiac surgery patients who bleed post-surgery. Its outcome will provide high-quality evidence to inform the management of bleeding following cardiac surgery.

trial registrationISRCTN 92114384. Registered on 16/04/2024. ISRCTN-ISRCTN92114384: PROthrombin complex concentrate versus fresh frozen Plasma for bleeding in adults undergoing HEart SurgerY (PROPHESY-2 trial).

Indexed as

Blood Coagulation FactorsCardiac Surgical ProceduresPlasmaPostoperative HemorrhageCost-Benefit AnalysisEnglandHumansTime FactorsTreatment OutcomeWalesBlood Coagulation Factorsprothrombin complex concentratesCardiacFresh frozen plasmaHaemorrhageProthrombin complex concentrateRandomised control trialSurgeryTransfusion

Identifiers

PMID41546086
PMCPMC12895633

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.