Fresh Frozen Plasma in Cardiac Surgery: Descriptive and Prognostic Study (PLASMACARD)
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|ClinicalTrials.gov Identifier: NCT00221741|
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : March 18, 2015
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.
|Condition or disease||Intervention/treatment|
|Heart Surgery Blood Loss, Surgical||Drug: Fresh Frozen Plasma (blood product)|
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.
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.
- To estimate the conformity of transfusion or lack of transfusion of FFP to French authorities recommendations.
- To describe the post-operative mortality and morbidity.
- To evaluate the prognostic role of FFP transfusion on mortality and morbidity
Prospective prognostic cohort study, with an exhaustive recruitment in participating cardiac surgery centers during the study period.
Centers: 16 French cardiac surgery centers.
- Coronary artery bypass grafting (CABG), valvular replacement, surgery for thoracic aorta aneurysm or dissection, heart graft.
- Serious bleeding or FFP transfusion during pre, per or post-operative period.
- Patient's consent for collecting medical data
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.
|Study Type :||Observational|
|Actual Enrollment :||1497 participants|
|Official Title:||PLASMACARD - Fresh Frozen Plasma in Cardiac Surgery: Descriptive and Prognostic Study|
|Study Start Date :||February 2004|
|Actual Study Completion Date :||March 2006|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00221741
|Département d'anesthésie-réanimation II (DAR II), Hôpital Haut-Lévêque, Av de Magellan|
|Pessac, France, 33604|
|Principal Investigator:||Maryse Puntous, Dr||University Hospital, Bordeaux|
|Study Director:||Gérard Janvier, Professor||University Hospital, Bordeaux|
|Study Chair:||Paul Perez, Dr||University Hospital, Bordeaux|