Early Intrapleural TPA Instillation Versus Late

NCT ID: NCT03167281

Last Updated: 2025-02-21

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-17
• Study Completion Date: 2021-03-10

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.

Conditions

Tissue Plasminogen Activator

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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 24-48 hours after chest tube placed.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

early tPA and DNase

Intervention Type: COMBINATION_PRODUCT

Early addition of tPA and DNase (immediately at chest tube placement) versus later (24-48 hours) after chest tube placement.

Interventions

early tPA and DNase

Early addition of tPA and DNase (immediately at chest tube placement) versus later (24-48 hours) after chest tube placement.

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Prisma Health-Midlands

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rohan Mankikar, MD

Role: PRINCIPAL_INVESTIGATOR

Prisma Health-Midlands

Locations

Palmetto Health Richland

Columbia, South Carolina, United States

Countries

United States

Related Links

http://scresearch.org/studies/search?utf8=%E2%9C%93&q=Mankikar&commit=GO

South Carolina Research Studies Directory

Other Identifiers

00058518

Identifier Type: -

Identifier Source: org_study_id