Efficacy and Safety of Platelet-rich Plasma on Bronchopleural Fistula
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Cure rate for bronchopleural fistula
研究概览
简要总结
Platelet-rich plasma(PRP), is a concentrate of platelet-rich plasma protein derived from whole blood. The main components of it are platelets, leukocytes and fibrin. Autologous PRP treatment can avoid the immune rejection caused by exogenous growth factor and the spread of disease. Evidence of the efficacy and safety of PRP has been proven in many studies. Bronchopleural fistula (BPF) represents a challenging clinical entity characterized by abnormal communication between the bronchial tree and the pleural space. Respiratory intervention has become one of the most common treatments to fight the disease. Although the short-term occlusion effect of conventional treatment methods of respiratory intervention is relatively easy to achieve, there is great uncertainty in the long-term treatment effect, and long-term large fistulas have little chance of healing. PRP has shown significant efficacy for hyperplastic scar of skin. Correspondingly, PRP will be applied as treatment of BPF to cure fistula.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with aged between 18 to 75
- •Subjects diagnosed with bronchopleural fistula (the sizes of the fistulas less than 4mm)
- •Subjects willing to accept PRP treatment
排除标准
- •Subjects with fistulas larger than 4mm
- •Subjects who cannot tolerate bronchoscopy due to severe cardiac disease or other major comorbidities
- •Pregnant or breastfeeding women
结局指标
主要结局
Cure rate for bronchopleural fistula
时间窗: within 4-6 weeks after administration
Proportion of patients who is no need for endotracheal intervention and with stable clinical symptoms after PRP treatment
次要结局
- the modified Medical Research Council dyspnea scale (mMRC scale)(within 4-6 weeks after administration)
- COPD Assessment Test (CAT)(within 4-6 weeks after administration)
研究者
ShiYue Li
Director of Department of Respiratory Medicine
Guangzhou Institute of Respiratory Disease
