Fresh Frozen Plasma in Cardiac Surgery: Descriptive and Prognostic Study

Completed

• Conditions: Heart Surgery; Blood Loss, Surgical

• Registration Number: NCT00221741
• Lead Sponsor: University Hospital, Bordeaux

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.

Study Timeline

• Study Start: 2004-02
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-22
• Study Completion: 2006-03
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-17
• Last Update Posted: 2015-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1497

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Département d'anesthésie-réanimation II (DAR II), Hôpital Haut-Lévêque, Av de Magellan; 🇫🇷 Pessac, France