NL-OMON43332已完成不适用
The effects of acetylsalicylic acid on immunoparalysis following human endotoxemia - SALYCENDO-study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Written informed consent
- •- Age *18 and *35 yrs
- •- Healthy (as confirmed by medical history, examination, ECG, blood sampling)
排除标准
- •* Use of any medication
- •* Use of COX inhibitors 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 peptic ulcer disease
- •* History or signs of hematological disease
- •* Thrombocytopenia (<150*10^9/ml) or anemia (hemoglobin < 8.0 mmol/L)
- •* History of glucose-6-phospate dehydrogenase deficiency
- •* History of intracranial hemorrhage
- •* 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 *mol/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 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 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
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