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

This study has been completed.
Sponsor:
Information provided by:
Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier:
NCT01246453
First received: November 18, 2010
Last updated: July 15, 2011
Last verified: July 2011
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier: NCT01246453     History of Changes
Other Study ID Numbers: EC07/90479
Study First Received: November 18, 2010
Last Updated: July 15, 2011
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

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

ClinicalTrials.gov processed this record on July 26, 2014