Status:
NOT_YET_RECRUITING
Stop Air Leak by Talc or Autologous Blood Patch Therapy
Lead Sponsor:
Chinese University of Hong Kong
Conditions:
Pneumothorax Spontaneous Secondary
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
Objectives: To compare the therapeutic efficacy and safety profiles of intrapleural talc pleurodesis versus autologous blood patch therapy(ABPT) in patients with secondary spontaneous pneumothorax(SSP...
Detailed Description
Pneumothorax, defined as the presence of air in the pleural space, is a common respiratory emergency that often necessitates prolonged hospitalisation. In cases where pneumothorax occurs in the settin...
Eligibility Criteria
Inclusion
- Age 18 years or older
- Radiographically proven pneumothorax and underlying lung disease (either pre-existing or shown in diagnostic imaging at presentation)
- Spontaneous onset of pneumothorax, not related to trauma or iatrogenic procedure
- SSP with air leak persists for ≥3 days after the first radiographic evidence of pneumothorax
- Intend to administer talc or autologous blood patch therapy (ABPT) to stop the air leak as the next step of treatment
Exclusion
- A chest drain size smaller than Fr 12
- Bilateral pneumothorax
- Impaired blood clotting, including baseline INR \> 1.5, platelet \< 150 x 10\^9/L, use of therapeutic dose anticoagulant or dual-antiplatelet agents
- Active or recent (within 6 weeks) pleural infection
- Septicaemia or active extrapleural infection (e.g. pneumonia)
- Use of long-term systemic corticosteroids or immunosuppressant
- Previously received talc or ABPT to the ipsilateral pleural space for the current episode of pneumothorax
- Known sensitivity to talc
- Has had a previous pneumonectomy (either on the same or contralateral side)
- Patients who are pregnant or lactating (females of childbearing potential must have a negative pregnancy test before randomisation)
- Expected survival of less than three months from a different pathology to this pneumothorax (e.g. metastatic malignancy)
- Cognitively impaired and physically unable to follow the turning procedure during intrapleural procedure, or at risk of self-removing chest drain
- Inability to give informed consent
Key Trial Info
Start Date :
April 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2029
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06883188
Start Date
April 1 2026
End Date
March 31 2029
Last Update
March 19 2025
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