Clinical Research Directory

Stop Air Leak by Talc or Autologous Blood Patch Therapy

Sponsor: Chinese University of Hong Kong

Summary

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 investigators hypothesise that the proposed protocol will be feasible. Methods: A multicentre, two-arm, open-label, randomised controlled feasibility study which includes non-surgical subjects with SSP and PAL persisting for 3 days. Recruited subjects will be randomised in a 1:1 ratio to receive one dose of talc pleurodesis or ABPT, with follow-ups up to 3 months after hospital discharge. Discussion: The main outcome is to assess the feasibility of the trial protocol, based on the percentage of eligible patients enrolled and randomised, 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 72 hours after the study 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.

Official title: Stop Air Leak by Talc or Autologous Blood Patch Therapy for Persistent Air Leak in Secondary Spontaneous Pneumothorax (STOP Trial): A Pilot Randomised Trial

Key Details

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Interventions