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Early Intrapleural TPA Instillation Versus Late

Early Intrapleural TPA Instillation Versus Late

Status
Withdrawn
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03167281
Acronym
ELEVATE
Enrollment
0
Registered
2017-05-25
Start date
2017-02-17
Completion date
2021-03-10
Last updated
2025-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tissue Plasminogen Activator

Keywords

Chest tube, Thoracostomy, Pleural Diseases, Lung Neoplasms, Pulmonary Embolism, Pneumothorax, Thoracic Surgery, Deoxyribonucleases, Fibrinolytic Agents, Drainage, Pleural Effusion

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.

Interventions

COMBINATION_PRODUCTearly tPA and DNase

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

Sponsors

Prisma Health-Midlands
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Chest tube removal7 daysTime to chest tube removal

Secondary

MeasureTime frameDescription
Fluid drainage3 daysVolume of fluid drained after each tPA and DNase instillation
Need for other interventions4 daysPost tPA/DNase administration, the need for other interventions, such as surgery or additional chest tube, will be determined.
Discharge3 weeksTime to discharge

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026