Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00221741
Status:
COMPLETED
Last Update Posted:
2015-03-18
First Post:
2005-09-13
Brief Title:
Fresh Frozen Plasma in Cardiac Surgery Descriptive and Prognostic Study
Sponsor:
University Hospital Bordeaux
Organization:
University Hospital Bordeaux
Study Overview
Official Title:
PLASMACARD - Fresh Frozen Plasma in Cardiac Surgery Descriptive and Prognostic Study
Status:
COMPLETED
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PLASMACARD
Brief 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
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
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
Patients 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
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
Patients 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2002-006 | None | None | None |