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
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