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Fresh-frozen plasma transfusion did not reduce 30-day mortality in patients undergoing cardiopulmonary bypass cardiac surgery with excessive bleeding: the PLASMACARD multicenter cohort study

Authors

  • Adélaïde Doussau,

    Corresponding author
    1. Pole de Sante Publique et CIC-EC7, Unité de Soutien Méthodologique à la Recherche Clinique et Épidémiologique, CHU de Bordeaux, Bordeaux, France
    2. CIC-EC7 et Centre INSERM U897-Epidemiologie-Biostatistique, INSERM, Bordeaux, France
    3. ISPED, Centre INSERM U897-Epidemiologie-Biostatistique, Université Bordeaux, Bordeaux, France
    • Address reprint requests to: Adélaïde Doussau, Clinical Epidemiology Unit, Bordeaux University Hospital, Bat ISPED, Case 11, 146, rue Léo-Saignat, 33076 Bordeaux Cedex, France; e-mail: adelaide.doussau@isped.u-bordeaux2.fr.

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  • Paul Perez,

    1. Pole de Sante Publique et CIC-EC7, Unité de Soutien Méthodologique à la Recherche Clinique et Épidémiologique, CHU de Bordeaux, Bordeaux, France
    2. CIC-EC7 et Centre INSERM U897-Epidemiologie-Biostatistique, INSERM, Bordeaux, France
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  • Maryse Puntous,

    1. Unité de Sécurité Transfusionnelle et d'Hémovigilance, CHU de Bordeaux, Bordeaux, France
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  • Joachim Calderon,

    1. Service d'Anesthésie-Réanimation II, CHU de Bordeaux, Bordeaux, France
    2. Adaptation Cardiovasculaire à l'Ischémie U1034, Université Bordeaux, Pessac, France
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  • Michel Jeanne,

    1. EFSAL (Blood Tranfusion Center), Bordeaux, France
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  • Christine Germain,

    1. Pole de Sante Publique et CIC-EC7, Unité de Soutien Méthodologique à la Recherche Clinique et Épidémiologique, CHU de Bordeaux, Bordeaux, France
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  • Bertrand Rozec,

    1. Service d'anesthésie et de réanimation chirurgicale, CHU de Nantes, Nantes, France
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  • Virginie Rondeau,

    1. CIC-EC7 et Centre INSERM U897-Epidemiologie-Biostatistique, INSERM, Bordeaux, France
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  • Geneviève Chêne,

    1. Pole de Sante Publique et CIC-EC7, Unité de Soutien Méthodologique à la Recherche Clinique et Épidémiologique, CHU de Bordeaux, Bordeaux, France
    2. CIC-EC7 et Centre INSERM U897-Epidemiologie-Biostatistique, INSERM, Bordeaux, France
    3. ISPED, Centre INSERM U897-Epidemiologie-Biostatistique, Université Bordeaux, Bordeaux, France
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  • Alexandre Ouattara,

    1. Service d'Anesthésie-Réanimation II, CHU de Bordeaux, Bordeaux, France
    2. Adaptation Cardiovasculaire à l'Ischémie U1034, Université Bordeaux, Pessac, France
    3. Adaptation Cardiovasculaire à l'Ischémie, U1034, INSERM, Pessac, France
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  • Gérard Janvier,

    1. Service d'Anesthésie-Réanimation II, CHU de Bordeaux, Bordeaux, France
    2. Adaptation Cardiovasculaire à l'Ischémie U1034, Université Bordeaux, Pessac, France
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  • and for the PLASMACARD Study Group


  • The PLASMACARD study was funded by a grant from the French Ministry of Health (“PHRC 2002”), and AD received a study grant from the Fondation pour la Recherche Médicale (FRM). This study was sponsored by the Bordeaux University Hospital (CHU Bordeaux).

Abstract

Background

During on-pump cardiac surgery, hemorrhagic complications occur frequently. Fresh-frozen plasma (FFP) is widely transfused to provide coagulation factors. Yet, no randomized clinical trial has demonstrated its benefits on mortality. We assessed the relationship between therapeutic transfusion of FFP and 30-day mortality in cardiac surgery patients suffering from excessive bleeding in a prospective cohort study.

Study Design and Methods

Adult patients who underwent on-pump cardiac surgery and experienced excessive bleeding during the 48-hour perioperative period were recruited from 15 French centers between February 2004 and January 2006. Patients who received a preventive FFP transfusion were excluded. The association between FFP transfusion and all cause 30-day mortality was estimated using a Cox proportional hazards model, adjusted for confounding. A propensity score (PS) sensitivity analysis was also performed.

Results

Among 967 patients included in this study, 58.1% received FFP. The median dose was 11.3 mL/kg (interquartile range, 7.6-19.5). The cumulative 30-day mortality rate was 11.3% (95% confidence interval [CI], 9.5-13.5). FFP transfusion was associated with a higher 30-day mortality (hazard ratio [HR], 3.2; 95% CI, 1.7-6.1) in univariate analysis; however, after adjusting for prognostic factors, there was no longer any association (HR, 1.5; 95% CI, 0.8-3.0, p = 0.20). The results of the PS analysis were consistent with the adjusted analysis.

Conclusion

Among on-pump cardiac surgery patients experiencing excessive perioperative bleeding, there is no evidence of a beneficial impact of FFP transfusion on mortality.

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