Clinical Study on Autologous Platelet-rich Plasma (PRP) Treatment for Tracheobronchial Fistula

Study Overview
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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. Tracheobronchial fistula(TBF) refers to a pathological state in which there are abnormal passages between the trachea, bronchi and chest, esophagus, stomach, mediastinum, bile ducts and other organs or cavities. Bronchopleural fistulas and tracheobronchioesophageal fistulas are two common types og TBF, which are mainly manifested as choking on eating and repeated aspiration pneumonia. 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 TBF to cure fistula.

Official Title
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Clinical Study on Autologous Platelet-rich Plasma (PRP) Treatment for Tracheobronchial Fistula

Conditions
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Tracheobronchial Fistula

Intervention / Treatment
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* Procedure: Conventional treatment
* Procedure: PRP treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with aged between 18 to 75 Subjects diagnosed with Tracheobronchial fistula(the sizes of the fistulas less than 2cm) Subjects willing to accept PRP treatment Subjects tolerant to the bronchoscope Subjects signed informed consent Exclusion Criteria: Subjects with airway disease: congenital tracheobronchial fistula, recurrent polychondritis, etc; Subjects with the following pulmonary diseases: asthma, active pulmonary tuberculosis, pulmonary embolism, pneumothorax, pulmonary hypertension, etc; Subjects with malignant tumors or have a history of malignant tumors; Subjects with uncontrolled systemic infection; Subjects requiring anti-clotting drugs; Subjects with myocardial infarction, unstable angina, liver cirrhosis, acute glomerulonephritis, etc; Subjects with syphilis, HIV,HBV,HCV antibody positive; Subjects with Coagulation disorders such as hemophilia, giant platelet syndrome, thromboasthenia, etc; Subjects with severe renal damage, serum creatinine is more than 1.5 times the upper limit of the normal value; Subjects with liver disease or liver damage: ALT,AST, total bilirubin > 2 times the upper limit of the normal value; Subjects with a history of psychosis or suicide or epilepsy or other central nervous system diseases; Subjects with severe arrhythmias(e.g. ventricular tachycardia, frequent supraventricular tachycardia, atrial fibrillation, atrial flutter, etc.) or degree II above abnormal conduction; Subjects allergic to thrombin; Subjects accepted by any other clinical study within the first three months of the study; Subjects with poor compliance; Any other conditions might increase the risk of the patient or interfere with the clinical study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control group<br> | Procedure: Conventional treatment<br>* Conventional treatments for Tracheobronchial fistula, including the application of metallic endoclips<br>|
| Experimental: PRP group<br> | Procedure: PRP treatment<br>* PRP treatment following the conventional treatment for Tracheobronchial fistula<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cure rate for tracheobronchial fistula | Proportion of patients who is no need for endotracheal intervention and with stable clinical symptoms after three times of PRP treatment | within 6 months after administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical complete remission time | The interval time of the first intratracheal interventional therapy needed again after 3 times of PRP treatment | within 6 months after administration | 
| Times of unplanned treatment | The number of times a patient needs to be reviewed and treated by bronchoscopy for cough, expectoration and dyspnea | within 6 months after administration | 
| Incidence of complications associated with PRP treatment | fistula healing, sputum retention, etc. during follow-up | within 6 months after administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tracheobronchial fistula, Platelet-rich plasma