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Urokinase Versus Video-assisted Thoracoscopic to Treat Complicated Parapneumonic Empyema in Childhood

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: NCT00798278
Recruitment Status : Completed
First Posted : November 26, 2008
Last Update Posted : October 28, 2010
Sponsor:
Information provided by:
Spanish Society of Pediatric Surgery

Study Description
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Brief Summary:
A great controversy exists about which is the best method to perform the evacuation of the collection. The purpose of this study is to evaluate which is the best initial treatment to drain complicated parapneumonic empyema (stages II and III) in children: the present study raises a hypothesis of equivalence between both arms of treatment (chest drainage plus intrapleural urokinase or videothoracoscopic debridement).

Condition or disease Intervention/treatment Phase
Empyema Pneumonia Drug: Urokinase Procedure: Video-Assisted Thoracoscopic Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Exploratory Multicentre Clinical Trial to Compare the Efficacy of Urokinase Versus Video-assisted Thoracoscopic for Treatment of Complicated Parapneumonic Empyema in Childhood
Study Start Date : July 2008
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Urokinase

Arms and Interventions
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Arm Intervention/treatment
Experimental: Urokinase
urokinase infusion for 3 days
 Drug: Urokinase
Chest tube with intrapleural urokinase infusion for 3 days
Active Comparator: Thoracoscopic
Video-Assisted Thoracoscopic
 Procedure: Video-Assisted Thoracoscopic
Video-Assisted Thoracoscopic decortication


Outcome Measures
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Primary Outcome Measures :
  1. duration of the hospital stay after the treatment [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. complications of the treatment and complications of the disease [ Time Frame: 3 months ]
  2. total duration of the hospital stay [ Time Frame: 3 months ]
  3. number of days carrying the chest drain [ Time Frame: 3 months ]
  4. duration of the fever once the empyema has been drained [ Time Frame: 3 months ]

Eligibility Criteria
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Ages Eligible for Study:   1 Year to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients less than 15 years of age with pneumonia and persistent fever, and complicated parapneumonic empyema (septation or loculation seen on ultrasound or Rx thorax)stages II and III requiring an intervention to drain

Exclusion Criteria:

  • Existing contraindications or other previous conditions, hypertension, pneumothorax
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): NCT00798278


Locations
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Spain
Hospital Universitario Central de Asturias
Oviedo, Asturias, Spain
Hospital de Donostia
San Sebastián, Donostia, Spain, 20014
University Hospital Vall d'Hebron
Barcelona, Spain, 08035
Hospital Gregorio Marañón
Madrid, Spain
Hospital Infantil La Paz
Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Sponsors and Collaborators
Spanish Society of Pediatric Surgery
More Information
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Responsible Party: Claudia Marhuenda Irastorza, University Hospital Vall d'Hebron. Barcelona
ClinicalTrials.gov Identifier: NCT00798278    
Other Study ID Numbers: UKVATS2007
EudraCT Number 2007-003416-61
First Posted: November 26, 2008    Key Record Dates
Last Update Posted: October 28, 2010
Last Verified: November 2008
Keywords provided by Spanish Society of Pediatric Surgery:
Empyema
Urokinase
Thoracoscopic
Childhood
Additional relevant MeSH terms:
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Empyema
Infections
Suppuration
Inflammation
Pathologic Processes