Fibrinolytic Therapy Versus Medical Thoracoscopy

PHASE4CompletedINTERVENTIONAL
Enrollment

5

Participants

Timeline

Start Date

September 14, 2017

Primary Completion Date

February 4, 2020

Study Completion Date

February 4, 2020

Conditions
Pleural Diseases
Interventions
PROCEDURE

Chest thoracoscopy

Thoracoscopy will be performed as per standard protocols, with patient lateral decubitus position. Ten mLs of fluid will be collected to check for biomarkers. Adhesiolysis will be attempted and pleural irrigation will be done. At the end of the procedure, a drain will be inserted and connected to an underwater seal with a negative pressure suction

PROCEDURE

Chest fibrinolytic therapy

A chest tube will be inserted under ultrasonography into the most dependent area of the pleural effusion or into the largest loculation in patients with multi-loculated effusions. A of DNase and tPA will be given. Concurrent tPA and DNase will be administered intrapleurally through the chest tube followed by saline flush. The tube will then be clamped for 120 minutes and after which it will be connected back to wall suction. The intrapleural therapy will be given twice daily for a maximum of 6 doses.

DRUG

tPA

tPA administered intrapleurally through the chest tube followed by saline flush. The intrapleural therapy will be given twice daily for a maximum of 6 doses.

DRUG

DNase

DNase administered intrapleurally through the chest tube followed by saline flush. The intrapleural therapy will be given twice daily for a maximum of 6 doses.

Trial Locations (1)

32611

University of Florida, Gainesville

All Listed Sponsors
lead

University of Florida

OTHER

NCT03213834 - Fibrinolytic Therapy Versus Medical Thoracoscopy | Biotech Hunter | Biotech Hunter