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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01246453
Recruitment Status : Completed
First Posted : November 23, 2010
Last Update Posted : July 18, 2011
Sponsor:
Information provided by:
Hospital Universitari Vall d'Hebron Research Institute

Study Description
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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)

Condition or disease Intervention/treatment Phase
Empyema, Pleural Pleural Effusion Pleural Diseases Drug: Intrapleurally Alteplase vs Intrapleurally Urokinase Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 204 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : December 2003
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: urokinase Drug: Intrapleurally Alteplase vs Intrapleurally Urokinase
Alteplase 10 mg and urokinase 100000 intrapleurally administered, once daily for three days and if necessary 6 days
Active Comparator: Alteplase Drug: Intrapleurally Alteplase vs Intrapleurally Urokinase
Alteplase 10 mg and urokinase 100000 intrapleurally administered, once daily for three days and if necessary 6 days


Outcome Measures
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Primary Outcome Measures :
  1. 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. [ Time Frame: 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 :
  1. To evaluate the pleural and plasmatic levels of the fibrinolytic system markers after the treatment with alteplase vs urokinase [ Time Frame: Evaluation at three and 6 days of treatment ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01246453


Locations
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Spain
Hospital Vall d'Hebron
Barcelona, Catalunya, Spain, 5
Hospital Arnau de Vilanova
LLeida, Catalunya, Spain
Sponsors and Collaborators
Hospital Universitari Vall d'Hebron Research Institute
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier: NCT01246453    
Other Study ID Numbers: EC07/90479
First Posted: November 23, 2010    Key Record Dates
Last Update Posted: July 18, 2011
Last Verified: July 2011
Additional relevant MeSH terms:
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Empyema
Empyema, Pleural
Pleural Effusion
Pleural Diseases
Respiratory Tract Diseases
Suppuration
Infections
 Inflammation
Pathologic Processes
Respiratory Tract Infections
Tissue Plasminogen Activator
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action