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

Phase 4

Completed

• Conditions: Empyema, Pleural; Pleural Effusion; Pleural Diseases
• Interventions: Drug: Intrapleurally Alteplase vs Intrapleurally Urokinase

• Registration Number: NCT01246453
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2003-12
• Study First Submitted: 2010-11-18
• Study First Submitted QC: 2010-11-22
• Study First Posted: 2010-11-23
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2011-07
• Last Update Submitted: 2011-07-15
• Last Update Posted: 2011-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 204

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
urokinase	Intrapleurally Alteplase vs Intrapleurally Urokinase	-
Alteplase	Intrapleurally Alteplase vs Intrapleurally Urokinase	-

Primary Outcome Measures

Name	Time	Method
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.	Evaluation at three and 6 days of treatment	It will be also an evaluation at one month, six months and one year

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Hospital Vall d'Hebron; 🇪🇸 Barcelona, Catalunya, Spain

Hospital Arnau de Vilanova; 🇪🇸 LLeida, Catalunya, Spain