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临床试验/NCT02914795
NCT02914795已完成不适用

Platelet Function in Resuscitated Patients

Medical University of Graz1 个研究点 分布在 1 个国家目标入组 99 人开始时间: 2015年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
99
试验地点
1
主要终点
Platelet Inhibition Measured With Optical Aggregometry

研究概览

简要总结

Approx. 65% of resuscitated patients at the intensive care unit for internal medicine are due to myocardial infarction. Almost all patients are initially diagnosed and treated in the cath lab. Therapy usually consists of one or more stent implantations. After implantation of a coronary stent, dual platelet inhibition is necessary for 12 months. Insufficient platelet inhibition causes an pronounced increase in risk of stent thrombosis. Therefore, knowledge of the individual platelet function is valuable.

Several factors potentially promote a delayed or reduced mode of action of platelet function inhibitors in resuscitated patients:

  1. oral administration is impossible and medication needs to be administered via a gastric line.
  2. gastric absorption is delayed after resuscitation
  3. according to current guidelines patients are treated with therapeutic hypothermia. Including the time of rewarming cooling period is ~48h

详细描述

Patients after successful resuscitation associated to a myocardial infarction will be included into the study the morning after the index event. Patients get dual platelet inhibition at the discretion of the interventionist. Patients are treated with therapeutic hypothermia according to the local Standard operating procedure for 24h and rewarming is performed within an additional 20h. Platelet function is measured every morning and Aspirin mediated as well as P2Y12 (purinergic G protein-coupled receptors-12)-inhibition mediated platelet function inhibition is recorded. All relevant clinical data including APACHE (Acute Physiology and Chronic Health Evaluation) and SOFA ( Sequential Organ Failure Assessment score) scores are collected.

The degree of platelet inhibition over time (7 days) and differences between the three drugs tested will be evaluated by optical aggregometry and by using the commercial VerifyNow test system.

研究设计

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

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

入选标准

  • Myocardial infarction
  • dual platelet inhibition
  • resuscitation
  • therapeutic hypothermia

排除标准

  • 未提供

结局指标

主要结局

Platelet Inhibition Measured With Optical Aggregometry

时间窗: day 3

Median (Inter-Quartile Range) Collagen AUC values on Day 3 measured with optical aggregometry The more light signal is detected, the better thrombocyte function is.

次要结局

  • Number of Participants With Cumulative Clinical Endpoint of Death and Stent Thrombosis(7 days)

研究者

发起方
Medical University of Graz
申办方类型
Other
责任方
Sponsor

研究点 (1)

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