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

Pleural Effusion Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01246453
• Other study ID #: EC07/90479
• Status: Completed
• Phase: Phase 4
• First received: November 18, 2010
• Last updated: July 15, 2011
• Start date: December 2003
• Est. completion date: December 2010

Study information

• Verified date: July 2011
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 204
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Empyema
• Empyema, Pleural
• Pleural Diseases
• Pleural Effusion

Intervention

Drug:
• Intrapleurally Alteplase vs Intrapleurally Urokinase
Alteplase 10 mg and urokinase 100000 intrapleurally administered, once daily for three days and if necessary 6 days

Locations

Country	Name	City	State
Spain	Hospital Vall d'Hebron	Barcelona	Catalunya
Spain	Hospital Arnau de Vilanova	LLeida	Catalunya

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes