Fresh Frozen Plasma in Cardiac Surgery: Descriptive and Prognostic Study

NCT00221741 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1497

Last updated 2015-03-18

No results posted yet for this study

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.

Conditions

  • Heart Surgery
  • Blood Loss, Surgical

Interventions

DRUG

Fresh Frozen Plasma (blood product)

Sponsors & Collaborators

  • University Hospital, Bordeaux

    lead OTHER

Principal Investigators

  • Maryse Puntous, Dr · University Hospital, Bordeaux

  • Gérard Janvier, Professor · University Hospital, Bordeaux

  • Paul Perez, Dr · University Hospital, Bordeaux

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-02-29
Completion
2006-03-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00221741 on ClinicalTrials.gov