Actively Recruiting
Trial of Reduced Alteplase Dose for Parapneumonic Effusion (TRAPPE)
Led by Chinese University of Hong Kong · Updated on 2026-01-05
30
Participants Needed
2
Research Sites
191 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Trial of Reduced Alteplase Dose for Parapneumonic Effusion (TRAPPE)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical signs of uncontrolled pleural infection with incomplete fluid drainage at least 1 day after chest drain insertion and antibiotic treatment
- Plan to receive intrapleural fibrinolytic therapy
- Written informed consent given
You will not qualify if you...
- Previous intrapleural tPA treatment for the current pleural infection episode
- Known allergy to tPA or DNase
- Recent stroke, major bleeding, or major trauma
- Active bleeding or injury to intercostal artery during chest drain insertion
- Ongoing bleeding from the affected pleural space
- Puncture of a non-compressible vessel within the last 14 days
- Major surgery in the last 14 days
- Unprovoked gastrointestinal bleeding or brain hemorrhage within 3 months
- Current use of anticoagulation (except deep vein thrombosis prevention) or dual-antiplatelet drugs
- Use of systemic fibrinolytic or airway DNase therapy
- Long-term use of macrolide antibiotics
- Uncorrectable bleeding disorder or INR over 1.5
- Previous pneumonectomy on either side
- Presence of active bronchopleural fistula
- Under 18 years of age
- Pregnant or breastfeeding women (negative pregnancy test required for women of childbearing age)
- Expected survival less than 3 months due to other diseases
- Use of unregistered or investigational agents in the last 30 days
- Unable to provide informed consent
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Chinese University of Hong Kong
Hong Kong, Hong Kong, Hong Kong
Actively Recruiting
2
Prince of Wales Hospital
Hong Kong, Hong Kong, Hong Kong
Actively Recruiting
Research Team
K
Ka Pang Chan, MBChB
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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