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临床试验/NCT06095518
NCT06095518已完成不适用

DIC Markers and Thrombin Generation Parameters in Patients on ECMO Support: a Pilot Study

Queen Mary Hospital, Hong Kong1 个研究点 分布在 1 个国家实际入组 49 人开始时间: 2023年5月30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
发起方
入组人数
49
试验地点
1
主要终点
Composite of thrombotic and hemorrhagic events

研究概览

简要总结

To study the correlation between novel DIC markers and thrombin generation parameters with thrombotic and hemorrhagic complications of patients on ECMO support.

研究设计

研究类型
观察性
观察模型
队列研究
时间视角
前瞻性

入排标准

年龄范围
— 至 80 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • Age ≧ 18; AND
  • Admitted to the mixed medical-surgical intensive care units of Queen Mary Hospital or Tuen Mun Hospital in Hong Kong; AND
  • Require either veno-arterial (VA) or veno-venous (VV) extracorporeal membrane oxygenation (ECMO) support.

排除标准

  • Patients who are on central VA-ECMO support; OR
  • Patients with missing clinical data; OR
  • Patients with pre-existing thromboembolism requiring long term anticoagulation prior to ECMO cannulation; OR
  • Post-operative admissions

研究组 & 干预措施

Adult Intensive Care Unit, Queen Mary Hospital

干预措施: DIC markers and Thrombin Generation Parameters (Diagnostic Test)

Department of Intensive Care Unit, Tuen Mun Hospital

干预措施: DIC markers and Thrombin Generation Parameters (Diagnostic Test)

结局指标

主要结局

Composite of thrombotic and hemorrhagic events

时间窗: From the start of ECMO support to the end of ECMO support (which can be variable, typically around 5 days to 1 week)

Thrombotic events include circuit-related thrombosis (e.g. oxygenator failure requiring circuit change) OR Non-circuit-related thrombosis (e.g. new pulmonary embolism or deep vein thrombosis while on ECMO. Hemorrhagic events include bleeding at critical sites or requiring interventions.

次要结局

未报告次要终点

研究者

发起方
Queen Mary Hospital, Hong Kong
申办方类型
其他
责任方
主要研究者
主要研究者

Wincy Wing-Sze Ng

Associate Consultant, Adult Intensive Care Unit

Queen Mary Hospital, Hong Kong

研究点 (1)

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标识符

NCT 编号
NCT06095518
其他研究编号
UW 23-259

日期

首次提交
(2年前)
首次发布
(2年前)
主要完成日期
(去年)
研究完成日期
(9个月前)
最近核实
(3个月前)
最近更新
(2个月前)

监管与共享

FDA 监管药物
否
FDA 监管器械
否
个体参与者数据共享计划
UNDECIDED
是否有结果
否

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