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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01246453
First Posted: November 23, 2010
Last Update Posted: July 18, 2011
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.
Information provided by:
Hospital Universitari Vall d'Hebron Research Institute
  Purpose
  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 Intervention Phase
Empyema, Pleural Pleural Effusion Pleural Diseases Drug: Intrapleurally Alteplase vs Intrapleurally Urokinase Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Hospital Universitari Vall d'Hebron Research Institute:

Primary Outcome Measures:
  • 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:
  • 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 ]

Estimated Enrollment: 204
Study Start Date: December 2003
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier: NCT01246453     History of Changes
Other Study ID Numbers: EC07/90479
First Submitted: November 18, 2010
First Posted: November 23, 2010
Last Update Posted: July 18, 2011
Last Verified: July 2011

Additional relevant MeSH terms:
Pleural Effusion
Empyema
Pleural Diseases
Empyema, Pleural
Respiratory Tract Diseases
Suppuration
Infection
Inflammation
Pathologic Processes
Respiratory Tract Infections
Tissue Plasminogen Activator
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action