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Early Intrapleural TPA Instillation Versus Late (ELEVATE)

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ClinicalTrials.gov Identifier: NCT03167281
Recruitment Status : Terminated (lack of adequate recruitment)
First Posted : May 25, 2017
Last Update Posted : March 15, 2021
Sponsor:
Information provided by (Responsible Party):
Dr. Rohan Arya, Prisma Health-Midlands

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)
Actual Enrollment : 6 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
Actual Primary Completion Date : March 10, 2021
Actual Study Completion Date : March 10, 2021

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



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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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT03167281


Locations
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United States, South Carolina
Palmetto Health Richland
Columbia, South Carolina, United States, 29203
Sponsors and Collaborators
Prisma Health-Midlands
Investigators
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Principal Investigator: Rohan Mankikar, MD Prisma Health-Midlands
Additional Information:
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Responsible Party: Dr. Rohan Arya, Principal Investigator, Prisma Health-Midlands
ClinicalTrials.gov Identifier: NCT03167281    
Other Study ID Numbers: 00058518
First Posted: May 25, 2017    Key Record Dates
Last Update Posted: March 15, 2021
Last Verified: March 2021
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, Prisma Health-Midlands:
Chest tube
Thoracostomy
Pleural Diseases
Lung Neoplasms
Pulmonary Embolism
Pneumothorax
Thoracic Surgery
Deoxyribonucleases
Fibrinolytic Agents
Drainage
Pleural Effusion