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
  Purpose

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 Intervention
Heart Surgery
Blood Loss, Surgical
Drug: Fresh Frozen Plasma (blood product)

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Longitudinal
Official Title: PLASMACARD - Fresh Frozen Plasma in Cardiac Surgery: Descriptive and Prognostic Study

Resource links provided by NLM:


Further study details as provided by University Hospital, Bordeaux:

Enrollment: 1497
Study Start Date: February 2004
Study Completion Date: March 2006
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00221741

Locations
France
Département d'anesthésie-réanimation II (DAR II), Hôpital Haut-Lévêque, Av de Magellan
Pessac, France, 33604
Sponsors and Collaborators
University Hospital, Bordeaux
Programme hospitalier de recherche clinique
Investigators
Principal Investigator: Maryse Puntous, Dr University Hospital, Bordeaux
Study Director: Gérard Janvier, Professor University Hospital, Bordeaux
Study Chair: Paul Perez, Dr University Hospital, Bordeaux
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00221741     History of Changes
Other Study ID Numbers: 9293-02, 2002-006
Study First Received: September 13, 2005
Last Updated: June 28, 2007
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Bordeaux:
Heart surgery
Blood Loss, Surgical
Mortality
Blood Transfusion
Cohort Studies

Additional relevant MeSH terms:
Hemorrhage
Blood Loss, Surgical
Pathologic Processes
Intraoperative Complications

ClinicalTrials.gov processed this record on September 30, 2014