NCT03070912已完成不适用
Study of the Frequency of Hemorrhages Associated With the Functional Anomalies of Willebrand Factor in Emergency Patients of a Veino Arterial or Veinous ECMO
University Hospital, Lille7 个研究点 分布在 1 个国家目标入组 257 人开始时间: 2018年1月19日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 257
- 试验地点
- 7
- 主要终点
- Frequency of major bleeding
研究概览
简要总结
ECMO has improved the outcome of heart or respiratory failure and carcinogenic shock and are increasingly used. However bleeding complications occurring in up to 50% of patients are poorly understood and worsen the overall results. The aim is to investigate the occurence of bleeding and its frequency according to the type of ECMO either veno-arterial or veno-venous. The investigators also want to assess the relation of bleeding with von Willebrand Factor defects.
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
- 否
入选标准
- •informed consent of patient or person in charge
- •patient supplied by an ECMO for cardiac or respiratory failure and referred to Lille University Hospital
- •patient affiliated to "french social security"
排除标准
- •pregnant woman
- •no consent
- •no affiliation to
- •patient affiliated to '
- •preexisting bleeding disorders
结局指标
主要结局
Frequency of major bleeding
时间窗: During ECMO support, up to 3 weeks after implantation
Number of major bleeding events (BARC classification ) occurring within the time course of support by ECMO
次要结局
- Number of Participants With Abnormal VWF functional activities and multimeric profile according to the type of ECMO support (VA- or VV-ECMO)(1 hour, 24 hours and day seven after implantation)
- Number of Participants With Abnormal VWF functional activities and multimeric profile in 2 groups defined by the level of pulse pressure measured before ECMO weaning: high (> median) or low (< median) pulse pressure(During ECMO support, up to 3 weeks after implantation)
- Frequency of major bleeding events according to diabetes status(During ECMO support, up to 3 weeks after implantation)
- Number of Participants With Abnormal VWF functional activities and multimeric profile before and after the first reduction in VA-ECMO flow rate(During ECMO support, up to 3 weeks after implantation)
- Number of Participants With major bleeding events (BARC classification) before and after the first reduction in VA-ECMO flow rate(During ECMO support, up to 3 weeks after implantation)
- Number of Participants With major bleeding events (BARC classification) in 2 groups defined by the level of pulse pressure measured before ECMO weaning: high (> median) or low (< median) pulse pressure(During ECMO support, up to 3 weeks after implantation)
- Frequency of major thrombotic events according to diabetes status(During ECMO support, up to 3 weeks after implantation)
- Frequency of pro-thrombotic biological abnormalities(During ECMO support, up to 3 weeks after implantation)
研究者
研究点 (7)
Loading locations...
相似试验
终止
不适用
Interest in Evaluating Primary Hemostasis in Patients With Veno-venous Extracorporeal Membrane Oxygenation (ECMO)Patients With ECMONCT03248596Rennes University Hospital5
Unknown
不适用
Refractory IHCA and OHCA Treated With ECMOCardiac ArrestNCT01298050University of Milano Bicocca40
Unknown
不适用
Risk Factors Analysis for Acute Myocardial Infarction PatientsAMI - Acute Mesenteric IschemiaExtracorporeal Membrane Oxygenation ComplicationNCT05390658Genglong Liu80
已完成
不适用
Risk Factors of Bleeding Under Veno Arterial Membrane OxygenationExtracorporeal Membrane OxygenationBleedingComplicationNCT03888833Centre Hospitalier Universitaire Dijon278
Unknown
不适用
Feasibility and Prognosis of Early Rehabilitation in Patients With ECMOExtracorporeal Membrane OxygenationNCT05083624JinyanXing100