Clinical trial NCT01246453: Efficacy and Security of Intrapleurally Alteplase vs Urokinase for the Treatment of Complicated Parapneumonic Effusion and Empyema
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Empyema, Pleural
Pleural Effusion
Pleural Diseases
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
First posted: 2010-11-23
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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)


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

Primary outcomes:
measure: 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
Secondary outcomes:
measure: To evaluate the pleural and plasmatic levels of the fibrinolytic system markers after the treatment with alteplase vs urokinase
timeFrame: Evaluation at three and 6 days of treatment
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
state: Catalunya
city: LLeida
country: Spain
facility: Hospital Arnau de Vilanova
state: Catalunya
Study officials:
References:
citation: Aleman C, Porcel JM, Alegre J, Ruiz E, Bielsa S, Andreu J, Deu M, Sune P, Martinez-Sogues M, Lopez I, Pallisa E, Schoenenberger JA, Bruno Montoro J, de Sevilla TF. Intrapleural Fibrinolysis with Urokinase Versus Alteplase in Complicated Parapneumonic Pleural Effusions and Empyemas: A Prospective Randomized Study. Lung. 2015 Dec;193(6):993-1000. doi: 10.1007/s00408-015-9807-6. Epub 2015 Sep 30.