Empyema Treated With tPA & DNAse

Children's Mercy Hospital Kansas City

Status and phase: Withdrawn; Phase 3

Conditions: Empyema

Treatments: Biological: tPA plus dornase; Biological: tPA alone

Study type: Interventional

Funder types: Other

Identifiers

NCT01862458

12120552 (Other Identifier)

Details and patient eligibility

About

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.

Sex: All

Ages: Under 17 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 2 patient groups

tPA alone

Active Comparator group

Description:

tPA alone used to treat empyema

Treatment:

Biological: tPA alone

tPA plus dornase

Experimental group

Description:

tPA plus dornase used to treat empyema

Treatment:

Biological: tPA plus dornase