Stop Air Leak by Talc or Autologous Blood Patch Therapy (NCT06883188) | Clinical Trial Compass
Not Yet RecruitingPhase 2/3
Stop Air Leak by Talc or Autologous Blood Patch Therapy
30 participantsStarted 2026-04-01
Plain-language 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) complicated by persistent air leak(PAL), and to assess the trial feasibility for a subsequent full-scale, multicentre randomised controlled trial(RCT).
Hypothesis: Talc pleurodesis and ABPT demonstrate comparable efficacy in stopping PAL and facilitating chest drain removal within 5 days.
Design and subjects: This single-centre, two-arm, open-label pilot RCT will recruit 30 patients with SSP and PAL persisting ≥5 days. Eligible patients will be randomised in a 1:1 ratio to receive intrapleural talc pleurodesis or ABPT. Digital chest drain systems will continuously record air leak rates from 24 hours before randomization until 120 hours post-intervention, ensuring objective, real-time data capture. Patients will be followed till 90 days post-discharge.
Interventions: Recruited subjects with PAL ≥5 days will be randomized in 1:1 ratio to receive talc pleurodesis or ABPT.
Main outcome measures: The primary outcome is complete cessation of air leak and successful chest drain removal within 5 days after the intervention. Secondary outcomes include absolute and percentage changes in digitally measured air leak rates, duration of chest drainage, recurrence of ipsilateral pneumothorax, need for additional pleural interventions, and safety outcomes such as drain blockage and pleural infection.
Data analysis and expected results: Data will be analysed on an intention-to-treat basis for all randomised subjects with regression models adjusting for confounders. The pilot outcomes will inform sample size calculations and refine design parameters for the proposed full-scale multicentre RCT.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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-re…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Complete cessation of air leak within 5 days of study intervention