PRP Efficacy and Safety in BPF

Not Applicable

Completed

• Conditions: Bronchopleural Fistula
• Interventions: Procedure: PRP treatment

• Registration Number: NCT05304897
• Lead Sponsor: Guangzhou Institute of Respiratory Disease

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-22
• Study First Submitted QC: 2022-03-22
• Study First Posted: 2022-03-31
• Study Start: 2022-04-16
• Primary Completion: 2024-01-25
• Study Completion: 2024-01-25
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-19
• Last Update Posted: 2024-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• 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

Exclusion Criteria

• Subjects with fistulas larger than 4mm
• Subjects who cannot tolerate bronchoscopy due to severe cardiac disease or other major comorbidities
• Pregnant or breastfeeding women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PRP group	PRP treatment	-

Primary Outcome Measures

Name	Time	Method
Cure rate for bronchopleural fistula	within 4-6 weeks after administration	Proportion of patients who is no need for endotracheal intervention and with stable clinical symptoms after PRP treatment

Secondary Outcome Measures

Name	Time	Method
the modified Medical Research Council dyspnea scale (mMRC scale)	within 4-6 weeks after administration	The alleviation or aggravation of dyspnea assessed by the mMRC scale
COPD Assessment Test (CAT)	within 4-6 weeks after administration	Change of respiratory symptoms and quality of life evaluated by the CAT

Trial Locations

Locations (1)

Guangzhou Institute of Respiratory Disease, The First Affiliated Hospital of Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China