Early Intrapleural TPA Instillation Versus Late


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Verified May 2017 by Palmetto Health

Sponsor:

Information provided by (Responsible Party):

Dr. Rohan Mankikar, Palmetto Health

ClinicalTrials.gov Identifier:

NCT03167281

First received: May 22, 2017

Last updated: May 23, 2017

Last verified: May 2017

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.

Tissue Plasminogen Activator Combination Product: early tPA and DNase Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Early Intrapleural TPA Instillation Versus Late

Primary Outcome Measures:

Secondary Outcome Measures:

  • Fluid drainage [ Time Frame: 3 days ]

    Volume of fluid drained after each tPA and DNase instillation

  • 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.

  • Discharge [ Time Frame: 3 weeks ]

    Time to discharge

Estimated Enrollment: 60
Actual Study Start Date: February 17, 2017
Estimated Study Completion Date: February 16, 2018
Estimated Primary Completion Date: February 16, 2018 (Final data collection date for primary outcome measure)
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.

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.

Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03167281

Palmetto Health Richland
Columbia, South Carolina, United States, 29203
Contact: Principal Investigator         

Palmetto Health

Principal Investigator: Rohan Mankikar, MD Palmetto Health

Additional Information:

Responsible Party: Dr. Rohan Mankikar, Principal Investigator, Palmetto Health
ClinicalTrials.gov Identifier: NCT03167281     History of Changes
Other Study ID Numbers: 00058518
Study First Received: May 22, 2017
Last Updated: May 23, 2017
Individual Participant Data  
Plan to Share IPD: No

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 Palmetto Health:

Chest tube
Thoracostomy
Pleural Diseases
Lung Neoplasms
Pulmonary Embolism
Pneumothorax
Thoracic Surgery
Deoxyribonucleases
Fibrinolytic Agents
Drainage
Pleural Effusion

ClinicalTrials.gov processed this record on May 25, 2017