Fresh Frozen Plasma in Cardiac Surgery: Descriptive and Prognostic Study (PLASMACARD)
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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 Observational Model: Natural History Time Perspective: Longitudinal Time Perspective: Prospective |
| Official Title: | PLASMACARD - Fresh Frozen Plasma in Cardiac Surgery: Descriptive and Prognostic Study |
| Enrollment: | 1497 |
| Study Start Date: | February 2004 |
| Study Completion Date: | March 2006 |
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 |
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| France | |
| Département d'anesthésie-réanimation II (DAR II), Hôpital Haut-Lévêque, Av de Magellan | |
| Pessac, France, 33604 | |
| 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 May 23, 2013