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Empyema Treated With tPA & DNAse

Primary Purpose

Empyema

Status

Withdrawn

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

tPA alone

tPA plus dornase

About this trial

This is an interventional treatment trial for Empyema focused on measuring empyema, tPA, dornase

Eligibility Criteria

undefined - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Children's Mercy Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

tPA alone

tPA plus dornase

Arm Description

tPA alone used to treat empyema

tPA plus dornase used to treat empyema

Outcomes

Primary Outcome Measures

Length of stay

Secondary Outcome Measures

Full Information

NCT ID

NCT01862458

First Posted

May 17, 2013

Last Updated

January 27, 2016

Sponsor

Children's Mercy Hospital Kansas City

1. Study Identification

Unique Protocol Identification Number

NCT01862458

Brief Title

Empyema Treated With tPA & DNAse

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2016

Overall Recruitment Status

Withdrawn

Why Stopped

funding difficulty

Study Start Date

January 2016 (undefined)

Primary Completion Date

January 2016 (Actual)

Study Completion Date

January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Children's Mercy Hospital Kansas City

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Empyema

Keywords

empyema, tPA, dornase

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

tPA alone

Arm Type

Active Comparator

Arm Description

tPA alone used to treat empyema

Arm Title

tPA plus dornase

Arm Type

Experimental

Arm Description

tPA plus dornase used to treat empyema

Intervention Type

Biological

Intervention Name(s)

tPA alone

Intervention Type

Biological

Intervention Name(s)

tPA plus dornase

Primary Outcome Measure Information:

Title

Length of stay

Time Frame

3 weeks

10. Eligibility

Sex

All

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shawn D St. Peter, MD

Organizational Affiliation

Children's Mercy Hospital and Clinics

Official's Role

Principal Investigator

Facility Information:

Facility Name

Children's Mercy Hospital

City

Kansas City

State/Province

Missouri

ZIP/Postal Code

64108

Country

United States

12. IPD Sharing Statement

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Empyema Treated With tPA & DNAse

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