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

  • STATUS
    Recruiting
  • End date
    Jul 1, 2024
  • participants needed
    40
  • sponsor
    Guangzhou Institute of Respiratory Disease
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Updated on 24 April 2022
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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. 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.

Details
Condition Tracheobronchial Fistula
Treatment Conventional treatment, PRP Treatment
Clinical Study IdentifierNCT05304897
SponsorGuangzhou Institute of Respiratory Disease
Last Modified on24 April 2022

Eligibility

 Yes No Not Sure

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
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