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New treatment option for Pleural Infection
Official title Trial of Reduced Alteplase Dose for Parapneumonic Effusion (TRAPPE)
ClinicalTrials.gov ID: NCT05766124
What this study is testing
What is Tissue Plasminogen Activator?
Tissue Plasminogen Activator is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for pleural infection.
Also referred to as Alteplase.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Clinical features suggesting uncontrolled pleural infection with incomplete drainage of pleural effusion, at least 1 day after insertion of pleural...
- Intend to administer intrapleural fibrinolytic
- Written informed consent obtained
You likely can't join if
- 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.
See the full eligibility 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
- 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 negative pregnancy test before randomisation).
- Expected survival less than three months from a different pathology to this empyema (e.g. metastatic lung carcinoma).
- Use of agents under research or not registered in the 30 days prior to the study.
- Inability to give informed consent.
The study team makes the final eligibility decision.
Where it's taking place
- Hong Kong, Hong Kong, Hong Kong
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hong Kong, Hong Kong, Hong Kong. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.