Stop Air Leak by Talc or Autologous Blood Patch Therapy

Background: A pilot study to assess the feasibility of a randomisation trial protocol comparing intrapleural talc pleurodesis versus autologous blood patch therapy (ABPT) in patients with secondary spontaneous pneumothorax (SSP) complicated by persistent air leak (PAL). The proposed randomised protocol comparing talc pleurodesis and ABPT will be feasible and acceptable. Methods: A multi-centre, two-arm, open-label, randomised controlled feasibility study which includes subjects with SSP and PAL persisting for 5 days eligible for intrapleural therapy, with follow-ups till 3 months after hospital discharge. Recruited subjects will be randomised in 1:1 ratio to receive one dose of talc pleurodesis or ABPT. Discussion: The main outcome is the feasibility of the trial protocol, based on the percentage of eligible patients enrolled, retained to discharge, and completing 3 months of follow-up. Other important outcomes include complete cessation of air leak and successful chest drain removal within 3 days after the intervention, absolute and percentage changes in digitally measured air leak rates, duration of chest drainage, recurrence of ipsilateral pneumothorax, need for additional pleural interventions, safety outcomes such as drain blockage and pleural infection. Feasibility outcomes will be reported as descriptive data. Comparison of outcomes between the two treatment groups will be analysed on an intention-to-treat basis. Safety outcomes will be reported descriptively for each group. The reported estimates of recruitment rates, adherence, follow-up completeness, and variability and event rates for key clinical outcomes will be used, to inform sample size calculations for future studies incorporating the current study design.