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

Spanish Society of Pediatric Surgery

Status and phase: Completed; Phase 3

Conditions: Pneumonia; Empyema

Treatments: Drug: Urokinase; Procedure: Video-Assisted Thoracoscopic

Study type: Interventional

Funder types: Other

Identifiers

NCT00798278

EudraCT Number 2007-003416-61

UKVATS2007

Details and patient eligibility

About

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).

Enrollment: 200 estimated patients

Sex: All

Ages: 1 to 15 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Urokinase

Experimental group

Description:

urokinase infusion for 3 days

Treatment:

Drug: Urokinase

Thoracoscopic

Active Comparator group

Description:

Video-Assisted Thoracoscopic

Treatment:

Procedure: Video-Assisted Thoracoscopic