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Completed

NCT Number: NCT05304897

PRP Efficacy and Safety in BPF

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Guangzhou, Guangdong, 510120, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PRP treatment

Procedure

PRP treatment for bronchopleural fistula

Primary outcomes

  1. 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

Secondary outcomes

  1. the modified Medical Research Council dyspnea scale (mMRC scale)

    Time frame: within 4-6 weeks after administration

    The alleviation or aggravation of dyspnea assessed by the mMRC scale

  2. COPD Assessment Test (CAT)

    Time frame: within 4-6 weeks after administration

    Change of respiratory symptoms and quality of life evaluated by the CAT

Sponsors and collaborators

Lead sponsor

Guangzhou Institute of Respiratory Disease

Other

Registry information

Official study title

Efficacy and Safety of Platelet-rich Plasma on Bronchopleural Fistula

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 31, 2022
Registry last updated
Jun 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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