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临床试验/NCT03888833
NCT03888833已完成不适用

Risk Factors of Bleeding in Patients Undergoing Peripheral Veno Arterial Extra Corporeal Membrane Oxygenation

Centre Hospitalier Universitaire Dijon1 个研究点 分布在 1 个国家目标入组 278 人开始时间: 2006年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
278
试验地点
1
主要终点
Rate of major hemorrhagic episodes defined as follows: loss of over 2g dl-1 of hemoglobin in 24 h, bleeding rate over 20 ml kg-1 day-1 or blood transfusion over 10 ml kg-1 day-1

研究概览

简要总结

Veno arterial extracorporeal membrane oxygenation (VA ECMO) is used, for cardiogenic shock, refractory cardiac arrest and post cardiotomy cardiac failure. Bleeding is frequent complications during VA ECMO and is associated with increased mortality. The aim of our study was to identify early factors associated with major bleeding in patients supported by VA ECMO

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

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

  • Patients over 18 years treated by peripheral veno arterial membrane oxygenation

排除标准

  • 未提供

研究组 & 干预措施

Veno arterial extracorporeal membrane oxygenation

干预措施: ECMO (Device)

结局指标

主要结局

Rate of major hemorrhagic episodes defined as follows: loss of over 2g dl-1 of hemoglobin in 24 h, bleeding rate over 20 ml kg-1 day-1 or blood transfusion over 10 ml kg-1 day-1

时间窗: Through study completion, an average of 10 years

Our main objective was to evaluate risk factors independently associated with major hemorrhagic episode. We collected patient characteristics at the start of VA ECMO: age, gender, anthropometric information, medical history and chronic treatments. We also calculated SOFA and APACHE II scores on the day of VA ECMO implementation. We noted the indication for VA ECMO, any pre-cannulation treatments (fibrinolysis, aspirin, heparin), where VA ECMO was inserted and whether or not an intra-aortic balloon pump was present. With regard to various complications, we collected the quantity of delivered blood products , the site of bleeding initial temperature. The biological data were collected at initiation of VA ECMO.

次要结局

  • Rate of mortality(30 day)
  • Length of stay(Through study completion, an average of 10 years)
  • Duration of life support(Through study completion, an average of 10 years)
  • Ischemic and thrombotic complications(Through study completion, an average of 10 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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