Clinical Research Directory

Stop Air Leak by Talc or Autologous Blood Patch Therapy

Sponsor: Chinese University of Hong Kong

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.

Official title: A Pilot Randomised Study Comparing the Clinical Efficacy of Stopping Air Leak by Talc Pleurodesis or Autologous Blood Patch Therapy in Secondary Spontaneous Pneumothorax

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Interventions