Stop Air Leak by Talc or Autologous Blood Patch Therapy

NCT06883188 | Not Yet Recruiting Phase 2

• 1 other identifier: STOP
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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) 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.

Conditions

Pneumothorax Spontaneous Secondary

Keywords

Persistent air leak; talc pleurodesis; autologous blood patch therapy

Outcome Measures

Primary Outcomes (1)

• Complete cessation of air leak within 5 days of study intervention

  Complete cessation of air leak for more than 24 hours and successful chest drain removal within 5 days after talc pleurodesis or ABPT

  5 days

Secondary Outcomes (10)

• Change in the average rate of air leak

  5 days

• Time to air leak cessation

  30 days

• Length of hospital stay

  3 months

• Recurrence of pneumothorax

  3 months

• Number of patients requiring additional intervention

  3 months

Study Arms (2)

talc pleurodesis

EXPERIMENTAL

intrapleural instillation of talc slurry

Drug: talc powder

Autolougs blood patch therapy (ABPT)

ACTIVE COMPARATOR

intrapleural instillation of patient's venous blood

Biological: patient's own venous blood

Interventions

talc powder DRUG

intrapleural instillation of talc slurry

talc pleurodesis

patient's own venous blood BIOLOGICAL

intrapleural instillation of patient's own venous blood

Autolougs blood patch therapy (ABPT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

MeSH Terms

Interventions

Dimethyl Sulfoxide

Intervention Hierarchy (Ancestors)

Sulfoxides; Sulfur Compounds; Organic Chemicals

Study Officials

• David SC Hui, MD

  Chinese University of Hong Kong

  STUDY DIRECTOR

Central Study Contacts

Ka Pang Chan, MBChB

CONTACT

+852 3505 2211; chankapang@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This is a single-centre, two-arm, open-label, randomized controlled trial including patients with spontaneous secondary pneumothorax and persistent air leak. Eligible patients will be randomised in a 1:1 ratio to receive either intrapleural administration of talc or autologous blood patch therapy. The digitalised air leak rate will be monitored continuously from randomisation till the removal of chest drain. Important endpoints include the rate of successful chest drain removal and reduction in air leak within 5 days after intrapleural intervention. This study will follow patients through their hospital stay and outpatient visits at 30 and 90 days after randomisation.

Study Record Dates

• First Submitted: March 8, 2025
• First Posted: March 19, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): March 31, 2029
• Study Completion (Estimated): March 31, 2029
• Last Updated: March 19, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share