PRP Efficacy and Safety in BPF

NCT05304897 | Completed

• 1 other identifier: 20220315
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchopleural Fistula

Keywords

Bronchopleural Fistula; Platelet-rich plasma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (1)

PRP group

EXPERIMENTAL

Procedure: PRP treatment

Interventions

PRP treatment PROCEDURE

PRP treatment for bronchopleural fistula

PRP group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Guangzhou Institute of Respiratory Disease: lead

Study Sites (1)

Guangzhou Institute of Respiratory Disease, The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510120, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Respiratory Medicine

Study Record Dates

• First Submitted: March 22, 2022
• First Posted: March 31, 2022
• Study Start: April 16, 2022
• Primary Completion: January 25, 2024
• Study Completion: January 25, 2024
• Last Updated: June 21, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)