EUCTR2016-004303-32-NL进行中（未招募）1 期
ASsesment of Platelet function and Inhibition in patients Recovering from severe INfection - ASPIRIN-trial
VU university medical center0 个研究点目标入组 62 人开始时间: 2017年4月13日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 62
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •In order to be eligible to participate in the main-trial, a subject must meet all of the following criteria:
- •Primary clinical diagnosis of pneumonia
- •Primary clinical diagnosis of invasive urinary tract infection
- •Primary clinical diagnosis of cutaneous infection
- •18 years or older on the date of hospital presentation
- •Hospitalization for at least 24 hours
- •Having received at least 1 dose of antibiotics within 48 hours of admission.
- •In order to be eligible to participate in the sub-study, a subject must meet all of the following criteria:
- •Primary clinical diagnosis of pneumonia
- •Primary clinical diagnosis of invasive urinary tract infection
- •Primary clinical diagnosis of cutaneous infection
- •18 years or older on the date of hospital presentation
- •Hospitalization for at least 24 hours
- •Having received at least 1 dose of antibiotics within 48 hours of admission
- •Known stable cardiovascular disease. Stable cardiovascular disease defined as: coronary artery disease, peripheral vascular disease, or previous myocardial infarction (>12 months).
- •Known stable cardiovascular disease. Stable cardiovascular disease defined as: coronary artery disease, peripheral vascular disease, or previous myocardial infarction (>12 months).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 31
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 31
排除标准
- •A potential subject who meets any of the following criteria will be excluded from participation in the main-trial:
- •-Active metastatic cancer (c.q. malignancy)
- •-Allergy to salicylate
- •-Platelet count <120*109/l
- •-History of non-traumatic major bleeding
- •-Known bleeding diathesis
- •-Conditions which require antiplatelet therapy
- •-Usage of antiplatelet therapy
- •-Surgery 1 month prior to diagnosis
- •-Currently pregnant
- •-Chronic usage of medication which are known to influence platelet function other than antibiotics (e.g. NSAID’s, tirofiban, eptifibatide, abciximab, SSRI’s, clomipramine, amitriptyline, dipyridamole, verapamil, diltiazem , ginkgo biloba, ginseng, & St John’s wort)
- •A potential subject who meets any of the following criteria will be excluded from participation in the sub-study:
- •-Active metastatic cancer (c.q. malignancy)
- •-Platelet count <120*109/l
- •-History of non-traumatic major bleeding
- •-Known bleeding diathesis
- •-Surgery 1 month prior to diagnosis
- •-Currently pregnant
- •-Chronic usage of medication which are known to influence platelet function other than antibiotics or aspirin (e.g. NSAID’s, tirofiban, eptifibatide, abciximab, SSRI’s, clomipramine, amitriptyline, dipyridamole, verapamil, diltiazem , ginkgo biloba, ginseng, & St John’s wort)
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