Early Intrapleural TPA Instillation Versus Late

Tissue Plasminogen Activator Clinical Trial

— ELEVATE  

Official title:

Early Intrapleural TPA Instillation Versus Late

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03167281
• Other study ID #: 00058518
• Status: Withdrawn
• Phase: Phase 4
• Start date: February 17, 2017
• Est. completion date: March 10, 2021

Study information

• Verified date: January 2022
• Source: Prisma Health-Midlands
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 10, 2021
• Est. primary completion date: March 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Tissue Plasminogen Activator

Intervention

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

Locations

Country	Name	City	State
United States	Palmetto Health Richland	Columbia	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Prisma Health-Midlands

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Chest tube removal	Time to chest tube removal	7 days
Secondary	Fluid drainage	Volume of fluid drained after each tPA and DNase instillation	3 days
Secondary	Need for other interventions	Post tPA/DNase administration, the need for other interventions, such as surgery or additional chest tube, will be determined.	4 days
Secondary	Discharge	Time to discharge	3 weeks

External Links

•   South Carolina Research Studies Directory