Département d'anesthésie-réanimation II (DAR II), Hôpital Haut-Lévêque, Av de Magellan
Pessac, 33604, France
NCT Number: NCT00221741
Despite experts' recommendations, the consumption of Fresh frozen plasma (FFP) is very heterogeneous among French cardiac surgery centers. This probably reflects heterogeneous practices that are not characterized and whose outcomes on morbidity and mortality are not documented.
The principal objective of the study is to describe transfusional strategies of FFP in patients undergoing cardiac surgery. The other objectives are: to assess the conformity of FFP transfusion or lack of transfusion to current French authorities' recommendations, to describe the post-operative mortality and morbidity and to assess the prognostic role of FFP on mortality and morbidity. Prognostic analyses will take into account other prognostic factors of mortality and morbidity.
1500 patients undergoing cardiac surgery and presenting with a serious bleeding (or transfused with FFP without bleeding) will be included in the study.
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Notify Me18 year and older
All sexes
Observational
Pessac, 33604, France
Background
Fresh frozen plasma (FFP) transfusions recommendations are essentially based on experts' opinions. However, disparity in consumption of FFP by cardiac surgery centers in France probably reflects heterogeneous practices that are not well characterized. Furthermore, health outcomes of these strategies on morbidity and mortality are not documented.
Objectives
Primary: to describe transfusional strategies of FFP in patients undergoing cardiac surgery and either presenting a serious bleeding during pre, per or post-operative periods or transfused by FFP without a serious bleeding.
Secondary:
Study design
Prospective prognostic cohort study, with an exhaustive recruitment in participating cardiac surgery centers during the study period.
Eligibility criteria
Centers: 16 French cardiac surgery centers.
Patients:
Analysis
Descriptive analysis of transfusional strategies according to patients' characteristics, type of surgery and circumstances of transfusions.
Conformity to French authorities' current recommendations. Multivariate analysis of the prognostic role of FFP transfusion on 30-day mortality.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
University Hospital, Bordeaux
Other
PLASMACARD - Fresh Frozen Plasma in Cardiac Surgery: Descriptive and Prognostic Study
Acronym: PLASMACARD
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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