Early Intrapleural TPA Instillation Versus Late

Study Overview
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Brief Summary
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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
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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.

Official Title
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Early Intrapleural TPA Instillation Versus Late

Conditions
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Tissue Plasminogen Activator

Intervention / Treatment
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* Combination Product: early tPA and DNase


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: tPA and DNase<br>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<br>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<br>* Early addition of tPA and DNase (immediately at chest tube placement) versus later (24-48 hours) after chest tube placement.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chest tube removal | Time to chest tube removal | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fluid drainage | Volume of fluid drained after each tPA and DNase instillation | 3 days | 
| 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 | 
| Discharge | Time to discharge | 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chest tube, Thoracostomy, Pleural Diseases, Lung Neoplasms, Pulmonary Embolism, Pneumothorax, Thoracic Surgery, Deoxyribonucleases, Fibrinolytic Agents, Drainage, Pleural Effusion