Clinical trial NCT00221741: Fresh Frozen Plasma in Cardiac Surgery: Descriptive and Prognostic Study
Official title: PLASMACARD - Fresh Frozen Plasma in Cardiac Surgery: Descriptive and Prognostic Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Surgery
Blood Loss, Surgical
Keywords: Heart surgery
Blood Loss, Surgical
Mortality
Blood Transfusion
Cohort Studies
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2005-09-22
Enrollment: 1497
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: 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.

Detailed description: 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:

* 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

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:

* 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

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.

Eligibility criteria: Inclusion Criteria:

* 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 periods.
* Patient's consent for collecting medical data

Exclusion Criteria:

* Congenital heart disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Pessac
country: France
facility: Département d'anesthésie-réanimation II (DAR II), Hôpital Haut-Lévêque, Av de Magellan
Study officials:
affiliation: University Hospital, Bordeaux
name: Maryse Puntous, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Bordeaux
name: Gérard Janvier, Professor
role: STUDY_DIRECTOR
affiliation: University Hospital, Bordeaux
name: Paul Perez, Dr
role: STUDY_CHAIR
References: