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临床试验/NCT03028064
NCT03028064已完成不适用

Point of Care Testing of Platelet Function in Patients With Acute Upper Gastrointestinal Bleeding

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 476 人开始时间: 2017年1月3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
476
试验地点
1
主要终点
Active bleeding that requires interventions (endoscopic, radiologic or surgery)

研究概览

简要总结

Acute upper gastrointestinal bleeding (AUGIB) is a common medical emergency. In an ageing population, antiplatelet drugs are increasingly being prescribed for treatment and prophylaxis against cardiovascular thrombo-embolic events. In many patients, platelet dysfunction mostly acquired is the principal cause of bleeding. To clinicians, the management of patients on antiplatelet drugs or anticoagulants is a challenge. One has to carefully balance the bleeding against thrombo-embolic risks. Therefore measuring platelet function should be integral in the management plan. A quantitative measurement allows titration of platelet function in accordance with bleeding or thromboembolic risk. Platelet function has not been studied in a large cohort of patients with acute upper gastrointestinal bleeding. As a first step, the study will determine if platelet dysfunction is associated with clinical outcome. In this prospective, observational single centre cohort study of consecutive patients with overt signs of acute upper gastrointestinal bleeding, their platelet function by point of care tests (light transmittance aggregometry, verify now p2y12,the platelet function analysis system (PFA-100) upon their admissions. Patients will be followed up for 30 days after trial enrollment. The primary endpoint is defined as significant bleeding that requires interventions (endoscopic, radiologic or surgery). Secondary end points include cardio- and cerebrovascular thrombo-embolic events and all cause deaths. A receiver operating characteristic (ROC) curve analysis is calculated for each point-of-care test to evaluate if individual test can distinguish between patients with and without primary end point. This study aims to evaluate the capability of platelet function tests to predict clinical outcome in patients with AUGIB. Logistic regression models will then be built in search for independent correlates to the primary and secondary endpoints and to adjust for confounding variables.

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 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients with overt signs of acute upper gastrointestinal bleeding (melena, coffee ground or fresh hematemesis with or without circulatory instability)

排除标准

  • asymptomatic patients with anemia are absence of positive gastroscopic findings to support gastrointestinal bleeding.

结局指标

主要结局

Active bleeding that requires interventions (endoscopic, radiologic or surgery)

时间窗: within 30 days of trial inclusion

Data on whether patients experience further bleeding that requires interventions, the type of interventions and the time of further bleeding after trial inclusion, will be collected through electronic medical record

次要结局

  • All cause deaths, cardiovascular or cerebral thrombotic events(within 30 days of trial inclusion)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

James Yun-wong Lau

Professor

Chinese University of Hong Kong

研究点 (1)

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