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

This study has been completed.
Sponsor:
Collaborator:
Programme hospitalier de recherche clinique
Information provided by:
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT00221741
First received: September 13, 2005
Last updated: June 28, 2007
Last verified: June 2007

September 13, 2005
June 28, 2007
February 2004
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Complete list of historical versions of study NCT00221741 on ClinicalTrials.gov Archive Site
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Fresh Frozen Plasma in Cardiac Surgery: Descriptive and Prognostic Study
PLASMACARD - Fresh Frozen Plasma in Cardiac Surgery: Descriptive and Prognostic Study

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.

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.

Observational
Observational Model: Defined Population
Time Perspective: Longitudinal
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  • Heart Surgery
  • Blood Loss, Surgical
Drug: Fresh Frozen Plasma (blood product)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1497
March 2006
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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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00221741
9293-02, 2002-006
No
Not Provided
University Hospital, Bordeaux
Programme hospitalier de recherche clinique
Principal Investigator: Maryse Puntous, Dr University Hospital, Bordeaux
Study Director: Gérard Janvier, Professor University Hospital, Bordeaux
Study Chair: Paul Perez, Dr University Hospital, Bordeaux
University Hospital, Bordeaux
June 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP