Empyema Treated With tPA & DNAse

Empyema Clinical Trial

Official title:

Prospective Randomized Trial: Fibrinolysis With tPA (Tissue Plasminogen Activator) Versus tPA and DNAse in Children With Empyema

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01862458
• Other study ID #: 12120552
• Secondary ID: 12120552
• Status: Withdrawn
• Phase: Phase 3
• First received: May 17, 2013
• Last updated: January 27, 2016
• Start date: January 2016
• Est. completion date: January 2016

Study information

• Verified date: January 2016
• Source: Children's Mercy Hospital Kansas City
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 17 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Empyema

Intervention

Biological:
• tPA alone

• tPA plus dornase

Locations

Country	Name	City	State
United States	Children's Mercy Hospital	Kansas City	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Children's Mercy Hospital Kansas City

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of stay		3 weeks	No