Early Intrapleural TPA Instillation Versus Late (ELEVATE)

January 31, 2022 updated by: Dr. Rohan Arya, Prisma Health-Midlands
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Columbia, South Carolina, United States, 29203
        • Palmetto Health Richland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 98 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prisma Health-Midlands

Investigators

  • Principal Investigator: Rohan Mankikar, MD, Prisma Health-Midlands

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 17, 2017

Primary Completion (Actual)

March 10, 2021

Study Completion (Actual)

March 10, 2021

Study Registration Dates

First Submitted

May 22, 2017

First Submitted That Met QC Criteria

May 23, 2017

First Posted (Actual)

May 25, 2017

Study Record Updates

Last Update Posted (Actual)

February 1, 2022

Last Update Submitted That Met QC Criteria

January 31, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 00058518

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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