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临床试验/NCT06550505
NCT06550505已完成不适用

Evaluation and Follow-up of a Protocol for the Management of the Patient at High Risk Hemorrhagic in Cardiac Surgery by Monitoring Viscoelastic Hemostasis.

University Hospital, Brest1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年3月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
fresh frozen plasma transfusion

研究概览

简要总结

Evaluation and following of a protocol using viscoelastic test for the management of high risk patients in cardiac surgery

详细描述

Haemorragy is a frequent issue in cardiac surgery due to multiple contributing factors. Excessive bleeding as well as transfusion are associated with increased morbidity and mortality.

Haemostatic blood products (Fibrinogen, fresh frozen plasma, platelets) transfusion had historically been guided by routine coagulation tests (aPTT, PT, platelets and fibrinogen). However, the delay (Up to 60 minutes) often leads to an empirical use of blood products in a context where clinical judgment is unreliable due to the multiples mechanisms contributing to haemostatic failure.

Using viscoelastic tests (VET) in this context has several advantages :

  • A quicker response (with first results from 10 minutes)
  • An overall evaluation of haemostatic from the clot formation to its dissolution.

The use of VET has mainly been evaluated in cardiac surgery, with several recent meta-analysis : The use of transfusion algorithms based on VET is associated with less transfusions of red blood cell concentrates, plasma and platelets and also with less mortality, less re-interventions due to excessive bleeding and less post operative renal failure.

研究设计

研究类型
Observational
观察模型
Cohort
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

  • 未提供

排除标准

  • Pregnant women
  • Age < 18 years
  • Patients under guardianship
  • Opposition

结局指标

主要结局

fresh frozen plasma transfusion

时间窗: 48 hours

Proportion of patients transfused with fresh frozen plasma 48 hours after the surgery.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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