Thoracic TraumaNCT05935267
Thoracostomy Tube Irrigation: a Multi-Center Trial
An observational study of Thoracic Trauma, run by Methodist Health System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic Trauma
- What is being tested?
- thoracic irrigation
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Dec 2021to 31 Dec 2024
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- • 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.
Who cannot join
- 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
Show all 9Show fewer
- Pregnant or lactating women
- Prisoners
- Physician discretion
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Research Institute Methodist Health System
Dallas, Texas, 75203
About this study
Official title: Thoracostomy Tube Irrigation: a Multi-Center Trial Investigating Its Efficacy in the Reduction of Secondary Intervention for the Management of Retained Hemothorax
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.
Read the 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.
- Conditions
- Thoracic Trauma
- Being tested
- thoracic irrigation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thoracic irrigationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| control cohort | control cohort Receives: Procedure: thoracic irrigation | |
| irrigation cohort | irrigation cohort Receives: Procedure: thoracic irrigation | |
| standard cohort | standard cohort Receives: Procedure: thoracic irrigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with thoracic trauma
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.
Measured: Dec 2022 - Dec 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
- Study start30 Dec 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Methodist Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Truitt, MD, Principal investigator, The Methodist Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05935267
- Sponsor's protocol ID
- 039.GME.2021.D
- Status last verified
- Nov 2024
- First submitted
- 21 Feb 2022
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thoracostomy Tube Irrigation: a Multi-Center Trial Investigating Its Efficacy in the Reduction of Secondary Intervention for the Management of Retained Hemothorax
- ClinicalTrials.gov ID
- NCT05935267
- Acronym / sponsor ID
- 039.GME.2021.D
- Conditions
- Thoracic Trauma
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Methodist Health SystemUniversity, hospital or other
- Study start
- 30 Dec 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 7 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control cohort | – | Procedure: thoracic irrigationcontrol cohort |
| irrigation cohort | – | Procedure: thoracic irrigationirrigation cohort |
| standard cohort | – | Procedure: thoracic irrigationstandard cohort |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- • Trauma patients admitted with initial indication for TT placement of HTx or HPTx.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| thoracic irrigationWe 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. | Procedure or surgery | control cohort, irrigation cohort, standard cohort |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Truitt, MD principal investigator
The Methodist Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thoracic Trauma, run by Methodist Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with thoracic trauma (time frame: Dec 2022 - Dec 2023). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2024.