Efficacy and Security of Intrapleurally Alteplase vs Urokinase for the Treatment of Complicated P… (NCT01246453) | Clinical Trial Compass
CompletedPhase 4
Efficacy and Security of Intrapleurally Alteplase vs Urokinase for the Treatment of Complicated Parapneumonic Effusion and Empyema
Spain204 participantsStarted 2003-12
Plain-language summary
1. Objectives:
* Main objective: To evaluate the efficacy and safety of intrapleural alteplase vs urokinase in patients with complex complicated parapneumonic pleural effusion and empyema.
* To evaluate the pleural and plasmatic levels of the fibrinolytic system markers after the treatment with alteplase vs urokinase
* To evaluate the safety of alteplase in the treatment of complex complicated parapneumonic pleural effusion and empyema
2. Design: Multicentric, randomized, parallel, controlled and double blind
3. Main variable: Percentage of curation
4. Study population and number of patients: 204 patients with complex complicated parapneumonic pleural effusions and empyema
5. Duration of the treatment: Three days (main variable), and optional three days (secondary variable)
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Empyema and Complex Complicated Parapneumonic Pleural Effusion
Exclusion Criteria:
* Pregnancy or breastfeeding
* Critically illness
* Systemic anticoagulant treatment
* Coagulation Disorder
* Bronchopleural fistula
* Active bleeding
* Recent punction of noncompressive artery
* Stroke in the last 6 months
* Major intervention o major traumatism in the last 6 weeks
* Hypersensibility to urokinase or alteplase
* Severe Liver or kidney failure
* Inclusion in another interventional study in the last month
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To evaluate the efficacy and safety of intrapleural alteplase vs urokinase in patients with complex complicated parapneumonic pleural effusion and empyema during one year of follow-up.
Timeframe: Evaluation at three and 6 days of treatment
Trial details
NCT IDNCT01246453
SponsorHospital Universitari Vall d'Hebron Research Institute