Efficacy and Security of Intrapleurally Alteplase vs Urokinase for the Treatment of Complicated Parapneumonic Effusion and Empyema

Study Overview
=================
Brief Summary
-----------------
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 Design: Multicentric, randomized, parallel, controlled and double blind Main variable: Percentage of curation Study population and number of patients: 204 patients with complex complicated parapneumonic pleural effusions and empyema Duration of the treatment: Three days (main variable), and optional three days (secondary variable)

Official Title
-----------------
A Prospective, Randomized, Double Blind, Controlled Trial to Evaluate Efficacy and Security of Intrapleurally Alteplase vs Urokinase for the Treatment of Complicated Parapneumonic Effusion and Pleural Empyema

Conditions
-----------------
Empyema, Pleural, Pleural Effusion, Pleural Diseases

Intervention / Treatment
-----------------
* Drug: Intrapleurally Alteplase vs Intrapleurally Urokinase


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: urokinase<br> | Drug: Intrapleurally Alteplase vs Intrapleurally Urokinase<br>* Alteplase 10 mg and urokinase 100000 intrapleurally administered, once daily for three days and if necessary 6 days<br>|
| Active Comparator: Alteplase<br> | Drug: Intrapleurally Alteplase vs Intrapleurally Urokinase<br>* Alteplase 10 mg and urokinase 100000 intrapleurally administered, once daily for three days and if necessary 6 days<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | It will be also an evaluation at one month, six months and one year | Evaluation at three and 6 days of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the pleural and plasmatic levels of the fibrinolytic system markers after the treatment with alteplase vs urokinase |  | Evaluation at three and 6 days of treatment |