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

NCT ID: NCT00798278

Last Updated: 2010-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2010-09-30

Brief Summary

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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).

Detailed Description

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Conditions

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Empyema Pneumonia

Keywords

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Empyema Urokinase Thoracoscopic Childhood

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Urokinase

urokinase infusion for 3 days

Group Type EXPERIMENTAL

Urokinase

Intervention Type DRUG

Chest tube with intrapleural urokinase infusion for 3 days

Thoracoscopic

Video-Assisted Thoracoscopic

Group Type ACTIVE_COMPARATOR

Video-Assisted Thoracoscopic

Intervention Type PROCEDURE

Video-Assisted Thoracoscopic decortication

Interventions

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Urokinase

Chest tube with intrapleural urokinase infusion for 3 days

Intervention Type DRUG

Video-Assisted Thoracoscopic

Video-Assisted Thoracoscopic decortication

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

1 Year

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Spanish Society of Pediatric Surgery

OTHER

Sponsor Role lead

Responsible Party

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University Hospital Vall d'Hebron. Barcelona

Locations

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University Hospital Vall d'Hebron

Barcelona, Barcelona, Spain

Site Status

Hospital de Donostia

San Sebastián, Donostia, Spain

Site Status

Hospital Gregorio Marañón

Madrid, Madrid, Spain

Site Status

Hospital Infantil La Paz

Madrid, Madrid, Spain

Site Status

Hospital Universitario 12 de Octubre

Madrid, Madrid, Spain

Site Status

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, Spain

Site Status

Countries

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Spain

Other Identifiers

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EudraCT Number 2007-003416-61

Identifier Type: -

Identifier Source: secondary_id

UKVATS2007

Identifier Type: -

Identifier Source: org_study_id