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Early Intrapleural TPA Instillation Versus Late (ELEVATE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03167281
Recruitment Status : Recruiting
First Posted : May 25, 2017
Last Update Posted : September 3, 2018
Information provided by (Responsible Party):
Dr. Rohan Arya, Palmetto Health

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 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 : February 17, 2017
Estimated Primary Completion Date : February 16, 2020
Estimated Study Completion Date : February 16, 2020

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.

Primary Outcome Measures :
  1. Chest tube removal [ Time Frame: 7 days ]
    Time to chest tube removal

Secondary Outcome Measures :
  1. Fluid drainage [ Time Frame: 3 days ]
    Volume of fluid drained after each tPA and DNase instillation

  2. Need for other interventions [ Time Frame: 4 days ]
    Post tPA/DNase administration, the need for other interventions, such as surgery or additional chest tube, will be determined.

  3. Discharge [ Time Frame: 3 weeks ]
    Time to discharge

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03167281

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Contact: Rohan Mankikar, MD 803-799-5022
Contact: Rohan Arya, MD 803-799-5022

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United States, South Carolina
Palmetto Health Richland Recruiting
Columbia, South Carolina, United States, 29203
Contact: Principal Investigator         
Sponsors and Collaborators
Palmetto Health
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Principal Investigator: Rohan Mankikar, MD Palmetto Health

Additional Information:
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Responsible Party: Dr. Rohan Arya, Principal Investigator, Palmetto Health Identifier: NCT03167281     History of Changes
Other Study ID Numbers: 00058518
First Posted: May 25, 2017    Key Record Dates
Last Update Posted: September 3, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Dr. Rohan Arya, Palmetto Health:
Chest tube
Pleural Diseases
Lung Neoplasms
Pulmonary Embolism
Thoracic Surgery
Fibrinolytic Agents
Pleural Effusion