Heart SurgeryPLASMACARDNCT00221741
Fresh Frozen Plasma in Cardiac Surgery: Descriptive and Prognostic Study
An observational study of Heart Surgery and Blood Loss, Surgical, run by University Hospital, Bordeaux at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Surgery, Blood Loss, Surgical
- What is being tested?
- Fresh Frozen Plasma (blood product)
- How many people
- 1,497 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2004to Mar 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Congenital heart disease
Trial locations and contacts
1 site in 1 country.
France1 site
Département d'anesthésie-réanimation II (DAR II), Hôpital Haut-Lévêque, Av de Magellan
Pessac, 33604
About this study
Official title: 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.
Read the 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.
- Conditions
- Heart Surgery, Blood Loss, Surgical
- Being tested
- Fresh Frozen Plasma (blood product)
- Keywords
- Heart surgery, Blood Loss, Surgical, Mortality, Blood Transfusion, Cohort Studies
- Medical subject headings
- Blood Loss, Surgical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fresh Frozen Plasma (blood product)Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startFeb 2004
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart SurgeryStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 1,497 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maryse Puntous, Dr, Principal investigator, University Hospital, BordeauxGérard Janvier, Professor, Study director, University Hospital, BordeauxPaul Perez, Dr, Study chair, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00221741
- Sponsor's protocol ID
- 9293-02
- Other IDs
- 2002-006
- Acronym
- PLASMACARD
- Status last verified
- Mar 2015
- First submitted
- 13 Sep 2005
- Last updated
- 18 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PLASMACARD - Fresh Frozen Plasma in Cardiac Surgery: Descriptive and Prognostic Study
- ClinicalTrials.gov ID
- NCT00221741
- Acronym / sponsor ID
- PLASMACARD / 9293-02
- Conditions
- Heart Surgery, Blood Loss, Surgical
- Keywords
- Heart surgery, Blood Loss, Surgical, Mortality, Blood Transfusion, Cohort Studies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,497 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- Feb 2004
- Study completion
- Mar 2006 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Congenital heart disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fresh Frozen Plasma (blood product) | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maryse Puntous, Dr principal investigator
University Hospital, Bordeaux
Gérard Janvier, Professor study director
University Hospital, Bordeaux
Paul Perez, Dr study chair
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Surgery and Blood Loss, Surgical, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2015; AzTrials last refreshed its copy on 6 Nov 2026.