ELEVATE: Early Intrapleural TPA Instillation Versus Late

Sponsor

Prisma Health-Midlands (Other)

Overall Status

Withdrawn

CT.gov ID

NCT03167281

Collaborator

(none)

Enrollment

Location

Arms

48.7

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Tissue Plasminogen Activator	Combination Product: early tPA and DNase	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Early Intrapleural TPA Instillation Versus Late

Actual Study Start Date :

Feb 17, 2017

Actual Primary Completion Date :

Mar 10, 2021

Actual Study Completion Date :

Mar 10, 2021

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: 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.
Experimental: 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.	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.

Arm

Intervention/Treatment

No Intervention: 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.

Experimental: 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.

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.

Outcome Measures

Primary Outcome Measures

Chest tube removal [7 days]
Time to chest tube removal

Secondary Outcome Measures

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