Empyema Treated With tPA & DNAse

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

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01862458

Enrollment

Registered

2013-05-24

Start date

2016-01-31

Completion date

2016-01-31

Last updated

2016-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Empyema

Keywords

empyema, tPA, dornase

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.

Interventions

BIOLOGICALtPA alone

BIOLOGICALtPA plus dornase

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

No minimum to 17 Years

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

Design outcomes

Primary

Measure	Time frame
Length of stay	3 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026