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Fibrinolytic Agent
Treatment of Complicated Parapneumonic Effusion With Fibrinolytic Therapy Versus VATs Decortication
N/A
Waitlist Available
Led By Fredric Pieracci, MD, MPH
Research Sponsored by Denver Health and Hospital Authority
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up everyday for 5 days post study intervention, from admission to discharge, or for 28 days, whichever comes first.
Awards & highlights
No Placebo-Only Group
Summary
This study aims to standardize the treatment of pleural space (parapneumonic) infections by comparing the difference in outcomes between 2 methods of treatment: early VATS (Video Assisted Thorascopic Surgery) decortication versus fibrinolytic therapy. During treatment, the patient's coagulopathy status will also be evaluated.
Eligible Conditions
- Malignant Pleural Mesothelioma
- Pleural Empyema
- Parapneumonic Effusion
- Blood Clotting Disorder
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ everyday for 5 days post study intervention, from admission to discharge, or for 28 days, whichever comes first.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~everyday for 5 days post study intervention, from admission to discharge, or for 28 days, whichever comes first.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Hospital Length of Stay
Secondary study objectives
Changed in Coagulopathic Status
Chest Tube Days
Chest Tube Drainage
+8 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Active Control
Group I: Operative VATS decorticationActive Control1 Intervention
Operative group that will undergo early VATS decortication of complicated parapneumonic effusion/empyema
Group II: Non-operative Fibrinolytic TherapyActive Control1 Intervention
Non-operative group that will undergo instillation of the drugs DNAse and tPA (tissue plasminogen activator) together i.e. 5mg DNAse and 10mg tPA twice a day for up to six doses, through chest tube as treatment of the patient's complicated parapneumonic effusion/empyema. Fibrinolytic therapy = DNAse + tPA; these medications are not mutually exclusive.
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Who is running the clinical trial?
Denver Health and Hospital AuthorityLead Sponsor
104 Previous Clinical Trials
402,110 Total Patients Enrolled
Fredric Pieracci, MD, MPHPrincipal InvestigatorDenver Health and Hospital