Fresh Frozen Plasma in Cardiac Surgery: Descriptive and Prognostic Study (PLASMACARD)
|First Received Date ICMJE||September 13, 2005|
|Last Updated Date||June 28, 2007|
|Start Date ICMJE||February 2004|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00221741 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Fresh Frozen Plasma in Cardiac Surgery: Descriptive and Prognostic Study|
|Official Title ICMJE||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.
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.
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.
Prospective prognostic cohort study, with an exhaustive recruitment in participating cardiac surgery centers during the study period.
Centers: 16 French cardiac surgery centers.
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 Type ICMJE||Observational|
|Study Design ICMJE||Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Prospective
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Intervention ICMJE||Drug: Fresh Frozen Plasma (blood product)|
|Study Group/Cohort (s)||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||March 2006|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years and older|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||France|
|NCT Number ICMJE||NCT00221741|
|Other Study ID Numbers ICMJE||9293-02, 2002-006|
|Has Data Monitoring Committee||No|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||University Hospital, Bordeaux|
|Collaborators ICMJE||Programme hospitalier de recherche clinique|
|Information Provided By||University Hospital, Bordeaux|
|Verification Date||June 2007|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP