NL-OMON45383招募中不适用
The effects of human endotoxemia on the functional capacity of hematopoietic stem and progenitor cells - LPS-BM study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 12
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 64（—）
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
- •History or signs of atopic syndrome (asthma, rhinitis with medication and/or eczema)
- •Known anaphylaxis or hypersensitivity to the non-investigational products or their excipients.
- •History or signs of hematological disease (bone marrow dysfunction):
- •Thrombocytopenia (<150*10^9/ml) or anemia (hemoglobin < 8.0 mmol/L)
- •Abnormalities in leukocyte differential counts
- •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, or clinically significant acute illness, including infections, within 3 weeks before labeling day
- •Previous (participation in a study with) LPS administration
- •Any vaccination within 3 months prior to labeling day
- •Participation in a drug trial or donation of blood 3 months prior to labeling day
- •Recent hospital admission or surgery with general anesthesia (<3 months to labeling day)
- •Use of recreational drugs within 21 days prior to labeling 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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