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PRP Efficacy and Safety in BPF

Efficacy and Safety of Platelet-rich Plasma on Bronchopleural Fistula

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05304897
Enrollment
16
Registered
2022-03-31
Start date
2022-04-16
Completion date
2024-01-25
Last updated
2024-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchopleural Fistula

Keywords

Bronchopleural Fistula, Platelet-rich plasma

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.

Interventions

PROCEDUREPRP treatment

PRP treatment for bronchopleural fistula

Sponsors

Guangzhou Institute of Respiratory Disease
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Cure rate for bronchopleural fistulawithin 4-6 weeks after administrationProportion of patients who is no need for endotracheal intervention and with stable clinical symptoms after PRP treatment

Secondary

MeasureTime frameDescription
the modified Medical Research Council dyspnea scale (mMRC scale)within 4-6 weeks after administrationThe alleviation or aggravation of dyspnea assessed by the mMRC scale
COPD Assessment Test (CAT)within 4-6 weeks after administrationChange of respiratory symptoms and quality of life evaluated by the CAT

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026