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临床试验/NCT05304897
NCT05304897已完成不适用

Efficacy and Safety of Platelet-rich Plasma on Bronchopleural Fistula

Guangzhou Institute of Respiratory Disease1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2022年4月16日最近更新:
适应症

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

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

发起方
Guangzhou Institute of Respiratory Disease
申办方类型
Other
责任方
Principal Investigator
主要研究者

ShiYue Li

Director of Department of Respiratory Medicine

Guangzhou Institute of Respiratory Disease

研究点 (1)

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