PRP Efficacy and Safety in BPF

NCT ID: NCT05304897

Last Updated: 2024-06-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-16

Study Completion Date

2024-01-25

Brief Summary

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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

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Conditions

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Bronchopleural Fistula

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PRP group

Group Type EXPERIMENTAL

PRP treatment

Intervention Type PROCEDURE

PRP treatment for bronchopleural fistula

Interventions

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PRP treatment

PRP treatment for bronchopleural fistula

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guangzhou Institute of Respiratory Disease

OTHER

Sponsor Role lead

Responsible Party

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ShiYue Li

Director of Department of Respiratory Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Guangzhou, Guangdong, China

Site Status

Countries

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China

Other Identifiers

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20220315

Identifier Type: -

Identifier Source: org_study_id

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