Evidence map›Paper›PMID 26738468›Full record

ArticleCritical care (London, England)2016

Safety and efficacy of prothrombin complex concentrate as first-line treatment in bleeding after cardiac surgery.

Giangiuseppe Cappabianca, Giovanni Mariscalco, Fausto Biancari, Daniele Maselli, Francesca Papesso, Marzia Cottini, Sandro Crosta, Simona Banescu, Aamer B Ahmed, Cesare Beghi

Registry-linked trialOpen access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Critical care (London, England), 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04244981 (Efficacy of Prothrombin Complex Concentrate Reducing Perioperative Blood Loss in Cardiac Surgery, Compared With Fresh Frozen Plasma), which is not on this map. Cited by 31 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed, 5 pooled it
11.2field-weighted citation impact, top 1% of its field
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.

NCT04244981 phase4terminatednot on this mapstarted 2023, after this paper: background citation

Efficacy of Prothrombin Complex Concentrate Reducing Perioperative Blood Loss in Cardiac Surgery, Compared With Fresh Frozen Plasma: Study Protocol for a Non-inferiority, Randomized Controlled Trial

TypeinterventionalSponsorSHI JiaRan2023 to 2025Enrolled476ConditionsValvular Heart SurgeryArmsProthrombin Complex Concentrate, Human, Fresh Frozen Plasma
3 · Its place in the literature

Who cites it

31 citing papers in PubMed, 5 syntheses or guidelines pooled it, 126 citations in OpenAlex.

  1. Pooled it
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  8. The thrombelastometry parameter CTEuropean journal of trauma and emergency surgery : official publication of the European Trauma Society · 2026
    Article
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  11. 2024 EACTS/EACTAIC Guidelines on patient blood management in adult cardiac surgery in collaboration with EBCP.European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery · 2025
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors at 5 institutions in 4 countries.

Giangiuseppe CappabiancaDepartment of Surgical and Morphological Sciences, Cardiac Surgery Unit, Varese University Hospital, University of Insubria, Varese, Italy. giangiuseppe.cappabianca@ospedale.varese.it.
Giovanni MariscalcoDepartment of Cardiovascular Sciences, Clinical Sciences Wing, Glenfield Hospital, University of Leicester, Groby Road, Leicester, LE39QP, UK. giovannimariscalco@yahoo.it.
Fausto BiancariDepartment of Surgery, Oulu University Hospital, Oulu, Finland. faustobiancari@yahoo.it.
Daniele MaselliDepartment of Cardiovascular Surgery, Cardiac Surgery Unit, S.Anna Hospital Catanzaro, Catanzaro, Italy. 4maselli@gmail.com.
Francesca PapessoDepartment of Surgical and Morphological Sciences, Cardiac Surgery Unit, Varese University Hospital, University of Insubria, Varese, Italy. f.papesso@hotmail.com.
Marzia CottiniDepartment of Surgical and Morphological Sciences, Cardiac Surgery Unit, Varese University Hospital, University of Insubria, Varese, Italy. marzia.cottini@hotmail.it.
Sandro CrostaCardiac Intensive Care Unit, Varese University Hospital, University of Insubria, Varese, Italy. sandro.crosta@ospedale.varese.it.
Simona BanescuCardiac Intensive Care Unit, Varese University Hospital, University of Insubria, Varese, Italy. simona.banescu@ospedale.varese.it.
Aamer B AhmedDepartment of Anaesthesia and Critical Care, Glenfield Hospital, University Hospitals of Leicester NHS Trust, Leicester, UK. aamer.ahmed@uhl-tr.nhs.uk.
Cesare BeghiDepartment of Surgical and Morphological Sciences, Cardiac Surgery Unit, Varese University Hospital, University of Insubria, Varese, Italy. cesare.beghi@uninsubria.it.
University of Insubria · ITCardiovascular Research Center · BRGlenfield Hospital · GBOulu University Hospital · FIUniversity of Leicester · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundBleeding after cardiac surgery requiring surgical reexploration and blood component transfusion is associated with increased morbidity and mortality. Although prothrombin complex concentrate (PCC) has been used satisfactorily in bleeding disorders, studies on its efficacy and safety after cardiopulmonary bypass are limited.

methodsBetween January 2005 and December 2013, 3454 consecutive cardiac surgery patients were included in an observational study aimed at investigating the efficacy and safety of PCC as first-line coagulopathy treatment as a replacement for fresh frozen plasma (FFP). Starting in January 2012, PCC was introduced as solely first-line treatment for bleeding following cardiac surgery.

resultsAfter one-to-one propensity score-matched analysis, 225 pairs of patients receiving PCC (median dose 1500 IU) and FFP (median dose 2 U) were included. The use of PCC was associated with significantly decreased 24-h post-operative blood loss (836 ± 1226 vs. 935 ± 583 ml, p < 0.0001). Propensity score-adjusted multivariate analysis showed that PCC was associated with significantly lower risk of red blood cell (RBC) transfusions (odds ratio [OR] 0.50; 95% confidence interval [CI] 0.31-0.80), decreased amount of RBC units (β unstandardised coefficient -1.42, 95% CI -2.06 to -0.77) and decreased risk of transfusion of more than 2 RBC units (OR 0.53, 95% CI 0.38-0.73). Patients receiving PCC had an increased risk of post-operative acute kidney injury (AKI) (OR 1.44, 95% CI 1.02-2.05) and renal replacement therapy (OR 3.35, 95% CI 1.13-9.90). Hospital mortality was unaffected by PCC (OR 1.51, 95% CI 0.84-2.72).

conclusionsIn the cardiac surgery setting, the use of PCC compared with FFP was associated with decreased post-operative blood loss and RBC transfusion requirements. However, PCC administration may be associated with a higher risk of post-operative AKI.

Indexed as

Time FactorsAgedBlood Coagulation FactorsBlood Component TransfusionBlood Loss, SurgicalErythrocyte TransfusionFemaleHumansMaleMiddle AgedPlasmaPropensity ScoreThoracic Surgical ProceduresBlood Coagulation Factorsprothrombin complex concentrates

Identifiers

PMID26738468
PMCPMC4702344
OpenAlexW2227006959

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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.