Early Intrapleural TPA Instillation Versus Late (ELEVATE)

Prisma Health-Midlands

Status and phase: Withdrawn; Phase 4

Conditions: Tissue Plasminogen Activator

Treatments: Combination Product: early tPA and DNase

Study type: Interventional

Funder types: Other

Identifiers

NCT03167281

00058518

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

0 participants in 2 patient groups

tPA and DNase

No Intervention group

Description:

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.

Early tPA and DNase

Experimental group

Description:

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.

Treatment:

Combination Product: early tPA and DNase