Bronchopleural FistulaNCT05304897
PRP Efficacy and Safety in BPF
A study testing PRP treatment in people with Bronchopleural Fistula, run by Guangzhou Institute of Respiratory Disease at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Bronchopleural Fistula
- What is being tested?
- PRP treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteChina
- Study dates
- 16 Apr 2022to 25 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Subjects with fistulas larger than 4mm
- Subjects who cannot tolerate bronchoscopy due to severe cardiac disease or other major comorbidities
- Pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country.
China1 site
Guangzhou Institute of Respiratory Disease, The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510120
About this study
Official title: Efficacy and Safety of Platelet-rich Plasma on Bronchopleural Fistula
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
- Being tested
- PRP treatment
- Keywords
- Bronchopleural Fistula, Platelet-rich plasma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRP treatmentProcedure or surgery
PRP treatment for bronchopleural fistula
| Study group | Role | What they receive |
|---|---|---|
| PRP group | Experimental | Not described Receives: Procedure: PRP treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cure rate for bronchopleural fistula
Proportion of patients who is no need for endotracheal intervention and with stable clinical symptoms after PRP treatment
Measured: within 4-6 weeks after administration
Secondary outcomes (2)
the modified Medical Research Council dyspnea scale (mMRC scale)
The alleviation or aggravation of dyspnea assessed by the mMRC scale
Measured: within 4-6 weeks after administration
COPD Assessment Test (CAT)
Change of respiratory symptoms and quality of life evaluated by the CAT
Measured: within 4-6 weeks after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start16 Apr 2022
- Primary completion25 Jan 2024
- Study completion25 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchopleural FistulaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangzhou Institute of Respiratory Disease
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ShiYue Li, Guangzhou Institute of Respiratory Disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05304897
- Sponsor's protocol ID
- 20220315
- Status last verified
- Jun 2024
- First submitted
- 22 Mar 2022
- Last updated
- 21 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Platelet-rich Plasma on Bronchopleural Fistula
- ClinicalTrials.gov ID
- NCT05304897
- Acronym / sponsor ID
- 20220315
- Conditions
- Bronchopleural Fistula
- Keywords
- Bronchopleural Fistula, Platelet-rich plasma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Guangzhou Institute of Respiratory DiseaseUniversity, hospital or other
- Study start
- 16 Apr 2022 (actual)
- Primary completion
- 25 Jan 2024 (actual)
- Study completion
- 25 Jan 2024 (actual)
- First posted
- 31 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PRP group | Experimental | Procedure: PRP treatment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Subjects with fistulas larger than 4mm
- Subjects who cannot tolerate bronchoscopy due to severe cardiac disease or other major comorbidities
- Pregnant or breastfeeding women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRP treatmentPRP treatment for bronchopleural fistula | Procedure or surgery | PRP group |
Primary outcome
Cure rate for bronchopleural fistula
Time frame: within 4-6 weeks after administration
Proportion of patients who is no need for endotracheal intervention and with stable clinical symptoms after PRP treatment
2 secondary outcomes
the modified Medical Research Council dyspnea scale (mMRC scale)
Time frame: within 4-6 weeks after administration
COPD Assessment Test (CAT)
Time frame: within 4-6 weeks after administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRP treatment in people with Bronchopleural Fistula, run by Guangzhou Institute of Respiratory Disease at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cure rate for bronchopleural fistula (time frame: within 4-6 weeks after administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2024.