Fresh Frozen Plasma in Cardiac Surgery: Descriptive and Prognostic Study

Blood Loss, Surgical Clinical Trial

— PLASMACARD  

Official title:

PLASMACARD - Fresh Frozen Plasma in Cardiac Surgery: Descriptive and Prognostic Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00221741
• Other study ID #: 9293-02
• Secondary ID: 2002-006
• Status: Completed
• Phase: N/A
• First received: September 13, 2005
• Last updated: March 17, 2015
• Start date: February 2004
• Est. completion date: March 2006

Study information

• Verified date: March 2015
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1497
• Est. completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Blood Loss, Surgical
• Heart Surgery
• Hemorrhage

Intervention

Drug:
• Fresh Frozen Plasma (blood product)

Locations

Country	Name	City	State
France	Département d'anesthésie-réanimation II (DAR II), Hôpital Haut-Lévêque, Av de Magellan	Pessac

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France,