RecruitingPhase 2/3

Trial of Reduced Alteplase Dose for Parapneumonic Effusion (TRAPPE)

Hong Kong30 participantsStarted 2024-11-01

Plain-language summary

Objectives: A pilot study to assess the feasibility of a randomization trial protocol comparing low (2.5mg) and standard (10mg) doses of intrapleural tissue plasminogen activator (tPA) with deoxyribonucleases (DNase) in unresolved pleural infection. Hypothesis: The proposed randomized protocol comparing low dose and standard doses of intrapleural tPA (with DNase) therapy will be feasible and acceptable. Design and subjects: A single-center, two-arm, double-blinded, randomized controlled feasibility study which includes subjects with unresolved pleural infection eligible for intrapleural tPA/DNase injection, with follow-ups till 3 months after hospital discharge. Interventions: Recruited subjects will be randomized in 1:1 ratio to receive a maximum of 6 doses of intrapleural tPA (with DNase) starting at either 2.5mg or 10mg. A clinical decision is allowed at or after the third dose of tPA to continue with the assigned regimen (blinded) or convert to open-label use of 10mg doses of tPA to complete the course based on the clinical response. Main outcome measures: 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 survival at 3 months follow-up and without the need for surgical intervention, the need for additional pleural interventions, the number of decisions to convert to open-labelled use of 10mg intrapleural tPA, clinical and radiographic response after the treatment course, safety profiles, especially bleeding complications and the number and reason for protocol violation. Data analysis and expected results: Feasibility outcomes will be reported as descriptive data. Comparison of outcomes between the two treatment groups will be analyzed 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 and bleeding outcomes will be used, to inform the design and sample size considerations future studies incorporating the current study design

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Clinical features suggesting uncontrolled pleural infection with incomplete drainage of pleural effusion, at least 1 day after insertion of pleural drain (French size 12 or above) and administration of antibiotics. * Intend to administer intrapleural fibrinolytic * Written informed consent obtained Exclusion Criteria: * Previously received intrapleural tPA to the ipsilateral pleural space for the current episode of pleural infection. * Known sensitivity to tPA or DNase. * A coincidental stroke, major haemorrhage or major trauma. * Frank bleeding or evidence of puncture to the intercostal artery during chest drain insertion. * Ongoing frank bleeding from the ipsilateral pleural space. * Has had puncture of a non-compressible vessel in the previous 14 days. * Has had major surgery in the previous 14 days. * Has had unprovoked gastrointestinal bleeding or intracranial haemorrhage in the last 3 months. * Active use of anticoagulation (except prophylaxis for deep vein thrombosis) or dual-antiplatelet agents. * Active use of any systemic fibrinolytic therapy or any airway DNase therapy. * On long-term macrolide antibiotics (as they may interact with DNase). * Uncorrectable bleeding diathesis or baseline INR \> 1.5. * Has had a previous pneumonectomy (either on the same or contralateral side). * Presence of active bronchopleural fistula. * Age less than 18 years old. * Patients who are pregnant or lactating (females of childbearing potential must have a nega…

What they're measuring

Study feasibility

Timeframe: 90 days

Trial details

NCT IDNCT05766124

SponsorChinese University of Hong Kong

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-03-31

Contact for this trial

Ka Pang Chan, MBChB

35052211 chankapang@cuhk.edu.hk