Empyema Treated With tPA & DNAse

• Sponsor: Children's Mercy Hospital Kansas City (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT01862458
• Collaborator: (none)
• Enrollment: 0
• Location: 1
• Arms: 2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Empyema	Biological: tPA alone; Biological: tPA plus dornase	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Prospective Randomized Trial: Fibrinolysis With tPA (Tissue Plasminogen Activator) Versus tPA and DNAse in Children With Empyema
• Study Start Date: Jan 1, 2016
• Actual Primary Completion Date: Jan 1, 2016
• Actual Study Completion Date: Jan 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: tPA alone tPA alone used to treat empyema	Biological: tPA alone
Experimental: tPA plus dornase tPA plus dornase used to treat empyema	Biological: tPA plus dornase

Outcome Measures

Primary Outcome Measures

1. Length of stay [3 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's Mercy Hospital	Kansas City	Missouri	United States	64108

Sponsors and Collaborators

• Children's Mercy Hospital Kansas City

Investigators

• Principal Investigator: Shawn D St. Peter, MD, Children's Mercy Hospital and Clinics

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shawn St. Peter, Assoc Prof, Children's Mercy Hospital Kansas City
• ClinicalTrials.gov Identifier: NCT01862458
• Other Study ID Numbers: 12120552; 12120552
• First Posted: May 24, 2013
• Last Update Posted: Jan 28, 2016
• Last Verified: Jan 1, 2016

• Keywords provided by Shawn St. Peter, Assoc Prof, Children's Mercy Hospital Kansas City: empyema; tPA; dornase
• Additional relevant MeSH terms: Empyema

Study Results

No Results Posted as of Jan 28, 2016