Empyema Treated With tPA & DNAse

Phase 3

Withdrawn

• Conditions: Empyema
• Interventions: Biological: tPA alone; Biological: tPA plus dornase

• Registration Number: NCT01862458
• Lead Sponsor: Children's Mercy Hospital Kansas City

Brief Summary

The objective of this study is to scientifically evaluate a new substrate for fibrinolysis compared to our standard tPA.

The hypothesis, driven by a recent prospective trial, is that tPA may benefit from the addition of DNAse.

The primary outcome variable between the two techniques will be length of hospitalization after initiation of treatment.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-05-17
• Study First Submitted QC: 2013-05-22
• Study First Posted: 2013-05-24
• Status Verified: 2016-01
• Study Start: 2016-01
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Last Update Submitted: 2016-01-27
• Last Update Posted: 2016-01-28

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Patients less than 18 years of age requiring an intervention for empyema by one of the following:

• Septation or loculation seen on ultrasound or computed tomography or
• Greater than 10,000 white blood cells identified on pleural tap

Exclusion Criteria

• Immunodeficiency process
• Secondary diagnosis or condition that will keep them in the hospital beyond the empyema
• Existing contraindications to chest tube
• Documented allergy to one of the study medications

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
tPA alone	tPA alone	tPA alone used to treat empyema
tPA plus dornase	tPA plus dornase	tPA plus dornase used to treat empyema

Primary Outcome Measures

Name	Time	Method
Length of stay	3 weeks

Trial Locations

Locations (1)

Children's Mercy Hospital; 🇺🇸 Kansas City, Missouri, United States