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

Information source: Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Empyema, Pleural; Pleural Effusion; Pleural Diseases

Intervention: Intrapleurally Alteplase vs Intrapleurally Urokinase (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Hospital Universitari Vall d'Hebron Research Institute

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)

Clinical Details

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

Primary outcome: 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.

Secondary outcome: To evaluate the pleural and plasmatic levels of the fibrinolytic system markers after the treatment with alteplase vs urokinase

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Hospital Vall d'Hebron, Barcelona, Catalunya 5, Spain

Hospital Arnau de Vilanova, LLeida, Catalunya, Spain

Additional Information

Starting date: December 2003
Last updated: July 15, 2011

Page last updated: August 23, 2015

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