- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01862458
Empyema Treated With tPA & DNAse
Prospective Randomized Trial: Fibrinolysis With tPA (Tissue Plasminogen Activator) Versus tPA and DNAse in Children With Empyema
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Missouri
-
Kansas City, Missouri, United States, 64108
- Children's Mercy Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: tPA alone
tPA alone used to treat empyema
|
|
Experimental: tPA plus dornase
tPA plus dornase used to treat empyema
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Length of stay
Time Frame: 3 weeks
|
3 weeks
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12120552 (Other Identifier: Children's Mercy Hospital)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Empyema
-
National University of MalaysiaCompletedLoculated EmpyemaMalaysia
-
Nhan Pham Nguyen HienHo Trung Cuong; Trinh Nguyen Ha Vi; Tran Nhu Quynh; Vu Minh Thuy; Nguyen Thi Tuong...UnknownEmpyema Thoracis in ChildrenVietnam
-
Thomas Decker ChristensenOdense University Hospital; Rigshospitalet, Denmark; Aalborg University HospitalNot yet recruiting
-
Azienda Ospedaliera di PadovaHoffmann-La RocheUnknown
-
The Hospital for Sick ChildrenCanadian Institutes of Health Research (CIHR); Unity Health Toronto; Children... and other collaboratorsCompletedPleural EmpyemaCanada
-
BERBERI ANTOINELebanese UniversityCompletedSinus; Empyema, Maxillary (Chronic)Lebanon
-
University Hospital, Basel, SwitzerlandPfizer; Lancardis FoundationTerminatedComplicated Parapneumonic Effusion | Pleural EmpyemaGreece, Italy, Switzerland
-
Centre Hospitalier Universitaire, AmiensCompleted
-
Dr. Wiley ChungRecruiting
-
Alexandria UniversityRecruiting
Clinical Trials on tPA alone
-
University of MalayaUnknownTranspalatal Arch (TPA) | Oral Health Related Quality of Life (OHRQoL) | Oral Health Impact Profile Short Version 14 (OHIP 14) | Orthodontic Pain | Three Dimensional (3D) Orthodontic DeviceMalaysia
-
Cerevast Medical, Inc.UnknownAcute Ischemic StrokeUnited States
-
Xinqiao Hospital of ChongqingCSPC RECOMGEN PHARMACEUTICAL (GUANGZHOU) CO.,LTDRecruitingStroke, Ischemic | Stroke, AcuteChina
-
University of GenovaUniversity of MichiganCompletedComplicated Impacted ToothItaly
-
University of North Carolina, Chapel HillGenentech, Inc.CompletedIschemic StrokeUnited States
-
Children's Mercy Hospital Kansas CityCompleted
-
General Hospital of Shenyang Military RegionRecruiting
-
University of PennsylvaniaGenentech, Inc.TerminatedDialysis Catheter Fibrin Sheath | Clotted Dialysis Catheter | Catheter MalfunctionUnited States
-
Cerevast Therapeutics, Inc.Terminated
-
Beijing Tiantan HospitalNational Natural Science Foundation of China; Beijing Municipal Science & Technology... and other collaboratorsRecruiting