NCT00221741

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,497

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2004

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
Last Updated

March 18, 2015

Status Verified

March 1, 2015

First QC Date

September 13, 2005

Last Update Submit

March 17, 2015

Conditions

Heart SurgeryBlood Loss, Surgical

Keywords

Heart surgeryBlood Loss, SurgicalMortalityBlood TransfusionCohort Studies

Interventions

Fresh Frozen Plasma (blood product)DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Congenital heart disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Département d'anesthésie-réanimation II (DAR II), Hôpital Haut-Lévêque, Av de Magellan

Pessac, 33604, France

Location

MeSH Terms

Conditions

Blood Loss, Surgical

Condition Hierarchy (Ancestors)

HemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsIntraoperative Complications

Study Officials

  • Maryse Puntous, Dr

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

  • Gérard Janvier, Professor

    University Hospital, Bordeaux

    STUDY DIRECTOR

  • Paul Perez, Dr

    University Hospital, Bordeaux

    STUDY CHAIR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 22, 2005

Study Start

February 1, 2004

Study Completion

March 1, 2006

Last Updated

March 18, 2015

Record last verified: 2015-03

Locations

FR(1)