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临床试验/NCT00221741
NCT00221741已完成不适用

PLASMACARD - Fresh Frozen Plasma in Cardiac Surgery: Descriptive and Prognostic Study

University Hospital, Bordeaux1 个研究点 分布在 1 个国家目标入组 1,497 人开始时间: 2004年2月最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,497
试验地点
1

研究概览

简要总结

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.

详细描述

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:

研究设计

研究类型
Observational
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Congenital heart disease

研究者

发起方
University Hospital, Bordeaux
申办方类型
Other
责任方
Sponsor

研究点 (1)

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