Empyema Treated With tPA & DNAse

NCT ID: NCT01862458

Last Updated: 2016-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2016-01-31

Brief Summary

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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

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Conditions

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Empyema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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tPA alone

tPA alone used to treat empyema

Group Type ACTIVE_COMPARATOR

tPA alone

Intervention Type BIOLOGICAL

tPA plus dornase

tPA plus dornase used to treat empyema

Group Type EXPERIMENTAL

tPA plus dornase

Intervention Type BIOLOGICAL

Interventions

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tPA alone

Intervention Type BIOLOGICAL

tPA plus dornase

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Mercy Hospital Kansas City

OTHER

Sponsor Role lead

Responsible Party

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Shawn St. Peter

Assoc Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shawn D St. Peter, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Mercy Hospital and Clinics

Locations

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Children's Mercy Hospital

Kansas City, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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12120552

Identifier Type: OTHER

Identifier Source: secondary_id

12120552

Identifier Type: -

Identifier Source: org_study_id

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