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临床试验/NCT05696210
NCT05696210尚未招募不适用

Evaluation of the 1-year Prognosis of Patients Under Veno-arterial Extracorporeal Membrane Oxygenation for Cardiogenic Shock With Blood Transfusion Requirement

Central Hospital, Nancy, France0 个研究点目标入组 110 人开始时间: 2023年1月20日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
110
主要终点
1-year survival

研究概览

简要总结

The primary objective of this work is to study the 1-year prognosis of patients who received Veno-arterial extracorporeal membrane oxygenation for cardiogenic shock with the need for blood transfusion. Secondary objectives are to determine whether the transfusion strategy used (liberal or restrictive) still has an impact on overall mortality. We will also determine the factors associated with overall in-hospital mortality and look at the impact of transfusion in relation to the risk of hemolysis on the consequences in the occurrence of long-term chronic renal failure.

详细描述

The study of the prognostic impact of blood transfusion at 1 year in patients assisted by Veno-arterial extracorporeal membrane oxygenation in the context of cardiogenic shock would provide objective answers and optimize the decision to set up this assistance with regard to the possible long-term consequences. This decision currently remains at the discretion of the expert teams managing these patients.

The inclusion of patients in a state of cardiogenic shock under Veno-arterial extracorporeal membrane oxygenation with the need for transfusion, will therefore allow the elaboration of a multicentric observational study interested in the prognosis at 1 year of patients under VA ECMO according to the adopted transfusion threshold.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patient of legal age (> 18 years) at the time of data collection.
  • •Hospitalization in intensive care unit
  • •Cardiogenic shock of medical or surgical etiology according to the SCAI definition (stage B to E)
  • •Need for cardio-circulatory assistance such as Veno-arterial extracorporeal membrane oxygenation for at least 24 hours

排除标准

  • •- Age < 18 years
  • •In-hospital and out-of-hospital cardiac arrest.
  • •Veno-arterial extracorporeal membrane oxygenation set up at a center other than the study centers.
  • •Veno-arterial extracorporeal membrane oxygenation set up for less than 24 hours
  • •Death within 24 hours

结局指标

主要结局

1-year survival

时间窗: date of start of intensive care hospitalization to date of discharge from intensive care hospitalization assessed up to 1 year

To evaluate the association of blood transfusion (and its volume of administration) with the 1-year prognosis of patients managed with Veno-arterial extracorporeal membrane oxygenation for medical or post cardiotomy cardiogenic shock

次要结局

  • All-cause mortality rate during hospitalization for cardiogenic shock with the need for Veno-arterial extracorporeal membrane oxygenation(date of start of intensive care hospitalization to date of discharge from intensive care hospitalization assessed up to 3 months)
  • 30-day mortality(date of start of intensive care hospitalization to date of discharge from intensive care hospitalization assessed up to 30 days)
  • Number of patients with stage 4 chronic kidney disease (GFR <30 mL/min) or with the need for chronic dialysis at 30 days.(date of start of intensive care hospitalization to date of discharge from intensive care hospitalization assessed up to 30 days)
  • Number of patients with stage 4 chronic kidney disease (GFR <30 mL/min) or with need for chronic dialysis at 1 year.(date of start of intensive care hospitalization to date of discharge from intensive care hospitalization assessed up to 1 year)

研究者

发起方
Central Hospital, Nancy, France
申办方类型
Other
责任方
Principal Investigator
主要研究者

Klein Thomas

Medical Doctor

Central Hospital, Nancy, France

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