Early Intrapleural TPA Instillation Versus Late

Phase 4

Withdrawn

• Conditions: Tissue Plasminogen Activator
• Interventions: Combination Product: early tPA and DNase

• Registration Number: NCT03167281
• Lead Sponsor: Prisma Health-Midlands

Brief Summary

Chest tubes are used for air or fluid removal from the pleural space. When a chest tube is placed, it can be hard for the fluid to drain.Tissue plasminogen activator (tPA) and DNase are given through the chest tube to help with draining the fluid. We are doing this research to see if early addition of tPA-DNase immediately after chest tube placement will help with better fluid draining.

Detailed Description

The purpose of this study is to determine the timing and efficacy of early administration and late administration of t-PA/DNase via thoracostomy (n=60). Patients will be identified from the Intensive Care Unit, Coronary Care Unit, and wards/stepdown units. Prior to chest tube placement, patients will be randomized to one of the two treatment arms (early use of t-PA-DNase verus late use of t-PA-DNase). Route of administration will be via their thoracostomy tube over a period of three days twice daily.

Study Timeline

• Study Start: 2017-02-17
• Study First Submitted: 2017-05-22
• Study First Submitted QC: 2017-05-23
• Study First Posted: 2017-05-25
• Primary Completion: 2021-03-10
• Study Completion: 2021-03-10
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-19
• Last Update Posted: 2025-02-21

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Adult patients, age 18 years or older
• Patients with an indication for a thoracostomy tube placement for a pleural effusion

Exclusion Criteria

• Patients that require a thoracostomy tube for a pneumothorax
• Pregnant women
• Sensitivity to t-PA, or DNase
• Patients taking carbamazepine or nitroglycerin
• Lung volume reduction surgery on side of pleural effusion

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early tPA and DNase	early tPA and DNase	10mg of t-PA and 5 mg of DNase in a 30 mL solution of water/saline administered via chest tube over three days twice daily with initial administration occurring at chest tube placement.

Primary Outcome Measures

Name	Time	Method
Chest tube removal	7 days	Time to chest tube removal

Secondary Outcome Measures

Name	Time	Method
Fluid drainage	3 days	Volume of fluid drained after each tPA and DNase instillation
Need for other interventions	4 days	Post tPA/DNase administration, the need for other interventions, such as surgery or additional chest tube, will be determined.
Discharge	3 weeks	Time to discharge

Trial Locations

Locations (1)

Palmetto Health Richland; 🇺🇸 Columbia, South Carolina, United States