NL-OMON38731撤回2 期
A feasibility and safety study of bronchoscopic intrabullous autologous blood instillation for the treatment of severe bullous emphysema. - BIABI study
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 20
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
- •- Age > 35 years
- •- Large bulla on CT scan were bullectomy is contraindicated or is actively avoided
- •- Hyperinflation --> TLC * 100%predcited and RV * 150% predicted
- •- Exertional breathlessness (mMRC >0)
- •- Optimum COPD treatment for at least 6 weeks
- •- No COPD exacerbation for at least 6 weeks
- •- Fewer than 3 admissions for infective exacerbations in the preceding 12 months
- •- Written informed consent
- •- Patients has stopped smoking for a minimum of 6 months prior to entering the study
排除标准
- •- Inability to obtain informed consent
- •- Co-morbidities that would render bronchoscopy or sedation unsafe
- •- Anaemia or other reasons precluding venesection
- •- Clinically significant bronchiectasis
- •- Arrhythmia or cardiovascular disease that poses a risk during procedure
- •- Lung nodule requiring further investigation or treatment
- •- Subject taking clopidogrel, warfarin, or other anticoagulants and unable to abstain for 5 days pre-procedure
研究者
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