PRP Efficacy and Safety in BPF

Bronchopleural Fistula Clinical Trial

Official title:

Efficacy and Safety of Platelet-rich Plasma on Bronchopleural Fistula

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05304897
• Other study ID #: 20220315
• Status: Completed
• Phase: N/A
• Start date: April 16, 2022
• Est. completion date: January 25, 2024

Study information

• Verified date: June 2024
• Source: Guangzhou Institute of Respiratory Disease
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: January 25, 2024
• Est. primary completion date: January 25, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Bronchopleural Fistula
• Fistula

Intervention

Procedure:
• PRP treatment
PRP treatment for bronchopleural fistula

Locations

Country	Name	City	State
China	Guangzhou Institute of Respiratory Disease, The First Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou Institute of Respiratory Disease

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cure rate for bronchopleural fistula	Proportion of patients who is no need for endotracheal intervention and with stable clinical symptoms after PRP treatment	within 4-6 weeks after administration
Secondary	the modified Medical Research Council dyspnea scale (mMRC scale)	The alleviation or aggravation of dyspnea assessed by the mMRC scale	within 4-6 weeks after administration
Secondary	COPD Assessment Test (CAT)	Change of respiratory symptoms and quality of life evaluated by the CAT	within 4-6 weeks after administration