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Thoracostomy Tube Irrigation: A Multi-Center Trial

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.
 
ClinicalTrials.gov Identifier: NCT05935267
Recruitment Status : Recruiting
First Posted : July 7, 2023
Last Update Posted : March 28, 2024
Sponsor:
Information provided by (Responsible Party):
Methodist Health System

Brief Summary:
All trauma patients ages 18 years or older presenting within 24 hours of blunt or penetrating injury resulting in traumatic HTx or HPTx will be eligible for enrollment. This prospective comparative study will consist of a non-irrigation control arm and a thoracic irrigation experimental arm. Thoracic irrigation is performed at the time of the initial TT placement, and is done at the discretion of the attending Trauma surgeon. All patients enrolled will be entered in a prospectively maintained thoracic trauma database. The primary outcome is need for secondary intervention, defined as additional TT placement, VATS, tissue plasminogen activator (tPA), or thoracotomy for the management of retained HTx. Secondary interventions will be screened according to indication. Only secondary interventions directed at management of retained collection will be considered in the analysis for our primary outcome. Secondary intervention aimed at persistent air leaks or post-pull PTx will be considered separately in any analysis.

Condition or disease Intervention/treatment
Thoracic Trauma Procedure: thoracic irrigation

Detailed Description:

All trauma patients ages 18 years or older presenting within 24 hours of blunt or penetrating injury resulting in traumatic HTx or HPTx will be eligible for enrollment. This prospective comparative study will consist of a non-irrigation control arm and a thoracic irrigation experimental arm. Thoracic irrigation is performed at the time of the initial TT placement, and is done at the discretion of the attending Trauma surgeon. All patients enrolled will be entered in a prospectively maintained thoracic trauma database. The primary outcome is need for secondary intervention, defined as additional TT placement, VATS(Viral Activation Transfusion Study), tissue plasminogen activator (tPA), or thoracotomy for the management of retained HTx. Secondary interventions will be screened according to indication. Only secondary interventions directed at management of retained collection will be considered in the analysis for our primary outcome. Secondary intervention aimed at persistent air leaks or post-pull PTx will be considered separately in any analysis.

This is a multicenter observational prospective data collection study. The study was initiated by Dr. Carver at the Medical College of Wisconsin and hosted as a Western Trauma Association Multicenter trial. We will not alter our standard of care practice at Methodist Dallas Medical Center in any way during the study duration. Data abstraction will occur from the electronic medical records program (EPIC). Each participating site will also practice according to their standard of care. If a site chooses to implement a TT irrigation protocol, approval should be obtained from their local divisional and IRB(Institutional Review Board) committees. If a participating site already performs thoracic irrigation, efforts should be made to follow the TT irrigation protocol provided with this study.

Each participating site will develop a method to screen for patients based on the resources available at their institution; this method should be included in the proposal submitted to their IRB.

The data at each participating site will be collected by a member of the study team and entered into the secure REDCap (Research Electronic Data Capture) database specifically created for this project. Data will be transferred from participating sites to Medical College of Wisconsin via REDCap. REDCap is a secure web application for building and managing online databases. All data entered into REDCap and transferred between sites will be deidentified. Only approved study staff at each site will be granted password protected access to the REDCap database. Ultimately, the Medical College of Wisconsin PI will have control over who can access the database and what type of access is granted.

The aim is to have all data collection completed by December 31, 2022 and to have data analysis completed by July 1, 2022.

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Thoracostomy Tube Irrigation: A Multi-Center Trial Investigating Its Efficacy in the Reduction of Secondary Intervention for the Management of Retained Hemothorax
Actual Study Start Date : December 30, 2021
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
control cohort
control cohort
Procedure: thoracic irrigation
We will start this study using 20% as the approximate national intervention rate, based on current literature, with the goal of detecting a 50% reduction in the experimental arm (i.e. 10% secondary intervention rate after thoracic irrigation). Therefore, we will plan to enroll 108 patients in the irrigation cohort and 324 patients in the control cohort. An interim analysis will be conducted once 54 patients have been enrolled in the irrigation cohort. The secondary intervention rate in the irrigation cohort and the standard cohort will be determined, and any adjustments to sample size will be made at that time.

irrigation cohort
irrigation cohort
Procedure: thoracic irrigation
We will start this study using 20% as the approximate national intervention rate, based on current literature, with the goal of detecting a 50% reduction in the experimental arm (i.e. 10% secondary intervention rate after thoracic irrigation). Therefore, we will plan to enroll 108 patients in the irrigation cohort and 324 patients in the control cohort. An interim analysis will be conducted once 54 patients have been enrolled in the irrigation cohort. The secondary intervention rate in the irrigation cohort and the standard cohort will be determined, and any adjustments to sample size will be made at that time.

standard cohort
standard cohort
Procedure: thoracic irrigation
We will start this study using 20% as the approximate national intervention rate, based on current literature, with the goal of detecting a 50% reduction in the experimental arm (i.e. 10% secondary intervention rate after thoracic irrigation). Therefore, we will plan to enroll 108 patients in the irrigation cohort and 324 patients in the control cohort. An interim analysis will be conducted once 54 patients have been enrolled in the irrigation cohort. The secondary intervention rate in the irrigation cohort and the standard cohort will be determined, and any adjustments to sample size will be made at that time.




Primary Outcome Measures :
  1. Number of participants with thoracic trauma [ Time Frame: Dec 2022 - Dec 2023 ]
    thoracic trauma resulting in the formation of pneumothorax (PTx), hemothorax (HTx), or hemopneumothorax (HPTx) is successfully managed with thoracostomy tube (TT) placement to evacuate blood and / or air from the pleural space.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All trauma patients ages 18 years or older presenting within 24 hours of blunt or penetrating injury resulting in traumatic HTx or HPTx will be eligible for enrollment.
Criteria

Inclusion Criteria:

  • • Trauma patients admitted with initial indication for TT placement of HTx or HPTx.

    • Patients must present to Methodist Dallas Medical Center within 24 hours of the traumatic event, either blunt or penetrating injury.
    • Follow up data available including radiologic studies performed within 24 hours of tube placement and hospital records to determine if any additional intervention(s) was performed.
    • 18 years of age or older.

Exclusion Criteria:

  • Less than 18 years of age.
  • Patients who had the TT removed (intentionally or unintentionally dislodged) prior to 24 hours TT duration.
  • Patients requiring operative exploration of the thoracic cavity within 6 hours following TT placement.
  • Patients with thoracotomy or VATS as initial treatment for HTx and/or HPTx
  • Patients with TT placed for isolated PTx
  • Patients who have a TT placed for HTx or HPTx more than 24 hours after presentation, or more than 24 hours after their traumatic event
  • Pregnant or lactating women
  • Prisoners
  • Physician discretion

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): NCT05935267


Contacts
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Contact: Crystee Cooper, DHEd 214-947-1285 clinicalresearch@mhd.com
Contact: Zaid Haddadin, MS 214-947-4604 clinicalresearch@mhd.com

Locations
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United States, Texas
Clinical Research Institute Methodist Health System Recruiting
Dallas, Texas, United States, 75203
Contact: Crystee Cooper, DHEd    214-941-1285    CrysteeCooper@mhd.com   
Contact: Zaid Haddadin, MS    2149474604    clinicalresearch@mhd.com   
Sponsors and Collaborators
Methodist Health System
Investigators
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Principal Investigator: Michael Truitt, MD Methodist Dallas Medical Center
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Responsible Party: Methodist Health System
ClinicalTrials.gov Identifier: NCT05935267    
Other Study ID Numbers: 039.GME.2021.D
First Posted: July 7, 2023    Key Record Dates
Last Update Posted: March 28, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No