EUCTR2016-001971-61-NL进行中（未招募）1 期
The effects of acetylsalicylic acid on immunoparalysis following human endotoxemia. - SALYCENDO-study
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
- Radboudumc
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
- Male
入选标准
- •- Written informed consent
- •- Age =18 and =35 yrs
- •- Healthy (as confirmed by medical history, examination, ECG, blood sampling)
- •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 30
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Use of any medication
- •Use of ASA within 6 weeks prior to the first endotoxemia day
- •Known anaphylaxis or hypersensitivity to acetylsalicylic acid or non-investigational products
- •History or signs of atopic syndrome (asthma, rhinitis with medication and/or eczema)
- •History of hematological disease
- •Thrombocytopenia (<150*10^9/ml) or anemia (hemoglobin < 8.0 mmol/L)
- •History of intracranial hemorrhage
- •Quantitative bleeding assessment tool (BAT) score>3
- •History, signs or symptoms of cardiovascular disease, in particular:
- •Previous spontaneous vagal collapse
- •History of atrial or ventricular arrhythmia
- •Cardiac conduction abnormalities on the ECG consisting of a 2nd degree atrioventricular block or a complete left bundle branch block
- •Hypertension (defined as RR systolic > 160 or RR diastolic > 90)
- •Hypotension (defined as RR systolic < 100 or RR diastolic < 50)
- •Renal impairment (defined as plasma creatinine >120 µmol/l)
- •Liver enzyme abnormalities (above 2x the upper limit of normal)
- •Medical history of any disease associated with immune deficiency
- •CRP > 20 mg/L, WBC > 12x109/L or < 4 x109/L, hemoglobin < 8 mmol/L or clinically significant acute illness, including infections, within 4 weeks before the first endotoxemia day
- •Previous (participation in a study with) LPS administration
- •Participation in a drug trial or donation of blood 3 months prior to first endotoxemia day
- •Any vaccination within 3 months prior to the first endotoxemia day until the end of the study
- •Recent hospital admission or surgery with general anesthesia (<3 months to endotoxemia day)
- •Use of recreational drugs within 21 days prior to the first endotoxemia day
- •Inability to personally provide written informed consent (e.g. for linguistic or mental reasons) and/or take part in the study
研究者
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