Hemothorax; TraumaticHTXDLYLAVGENCT06937450
Traumatic Hemothorax Drainage and Daily Lavage
A study testing CLR Irrigator, Serial Lavage and Drainage and 28 Fr Open Chest Tube in people with Hemothorax; Traumatic, run by University of Pennsylvania at 1 site in United States.
Trial summary
This HTX treatment study evaluates the effects of chest tube size and the benefits of daily irrigations on acute HTX. 20 acutely injured but stable trauma patients requiring a chest tube for HTX will be enrolled. Patients will be assigned a 28Fr or 14 Fr chest tube with serial lavage and drainage. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Hemothorax; Traumatic
- What is being tested?
- CLR Irrigator, Serial Lavage and Drainage and 28 Fr Open Chest Tube
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Mar 2025to 1 Aug 2027
- Phase
- Interventional
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Able to provide consent for the research study
- More than 15 years of age
- Presence of acute traumatic HTX or HTX-PTX diagnosed on chest CT scan within 24 hours of injury and clinical indication for drainage (hemothorax of moderate or large size greater then 300 mL)
- Hemodynamic stability (heart rate 120 beats per minute; systolic blood pressure 90 mmHg)
- Bilateral or unilateral hemothorax of greater than 300 mL HTX by Mergo Formula from chest CT
- Able to complete the entire study including randomization, tube placement, lavages and final CT Scan.
Who cannot join
- Less than 15 years of Age
- Prisoner
- Pregnant due to the risk of CT scans
- HTX or HTX-PTX not requiring drainage or drainage performed prior to randomization/enrollment
- Patients undergoing operative intervention (i.e. thoracotomy) as initial management of hemothorax (6) Persistent hemodynamic instability after initial resuscitation and CT imaging
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104
About this study
Official title: Traumatic Hemothorax Treatment With 14-Fr Pigtail Catheters or Large Bore (~28Fr) Chest Tubes With Daily Irrigation: A Pilot Single-Arm Intervention Study
This HTX treatment study evaluates the effects of chest tube size and the benefits of daily irrigations on acute HTX. 20 acutely injured but stable trauma patients requiring a chest tube for HTX will be enrolled. Patients will be assigned a 28Fr or 14 Fr chest tube with serial lavage and drainage. The endpoints will be HTX volume (by CT scan), complications, additional interventions, hospital length of stay, chest tube duration, provider feedback, and patient-reported outcomes.
Read the detailed description
This hemothorax (HTX) treatment study will evaluate the effects of chest tube size and daily lavage on HTX management outcomes. A total of 20 stable trauma patients requiring a chest tube for HTX will be recruited and consented. These patients will then undergo either 28Fr or 14Fr chest tube placement, depending on the preference of the treatment team at the time of placement. The study will include 10 patients with each type of chest tube (28Fr and 14Fr). Daily lavage will then be performed at 24h and 48h post-placement. Patients will be compared to historical control patients from the trauma registry who received either 28Fr or 14Fr chest tube placement followed by an initial lavage only. The primary endpoint will be the need for additional interventions such as tPA, additional chest tubes, thoracoscopic surgery (VATS), or thoracotomy. Secondary endpoints will include X-ray appearance at 72 hours, volume of HTX on CT at 72 hours, procedural complications, development of empyema (safety endpoint), development of delayed bleeding (safety endpoint), hospital length of stay, chest tube duration, provider feedback, and patient-reported outcomes.
- Conditions
- Hemothorax; Traumatic
- Being tested
- CLR Irrigator, Serial Lavage and Drainage, 28 Fr Open Chest Tube, Percutaneous 14Fr Chest Tube
- Medical subject headings
- Hemothorax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CLR IrrigatorDevice
All enrolled patients will have their hemothorax treated with a CLR device that allows for easy suction and irrigation through indwelling catheters,
Serial Lavage and DrainageProcedure or surgery
The current protocol is to do a singular lavage and drainage, this study will investigate the benefits of daily lavage.
28 Fr Open Chest TubeDevice
Patients will have a standard 28 Fr open chest tube or a percutaneous 14Fr chest tube placed.
Percutaneous 14Fr Chest TubeDevice
Patients will have a standard 28 Fr open chest tube, or a percutaneous 14Fr chest tube placed.
| Study group | Role | What they receive |
|---|---|---|
| Open 28 Fr Tube Thoracostomy with Daily Lavage and Drainage | Experimental | Open Tube Thoracostomy with Daily Lavage and Drainage Receives: Device: CLR Irrigator; Procedure: Serial Lavage and Drainage; Device: 28 Fr Open Chest Tube |
| Percutaneous 14-Fr Catheter with Daily Lavage and Drainage | Experimental | Percutaneous 14-Fr Catheter with Daily Lavage and Drainage Receives: Device: CLR Irrigator; Procedure: Serial Lavage and Drainage; Device: Percutaneous 14Fr Chest Tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remaining Hemothorax Volume at 72 hours
Assessed by CT and Mergo Formula
Measured: 72 hours
Secondary outcomes (7)
Number of patients requiring intervention for retained hemothorax (excluding those who require intervention for other treatment)
All interventions focused on resolving any remaining hemothorax
Measured: Through hospital discharge or 30 days
Patient Tolerability - Numerical Rating Scale Insertion Perception Experience
Patient perception of the drainage and lavage procedure ranging from 1 (tolerable) to 5 (worst experience of my life).
Did this Drainage and Lavage procedure resolve, lessen or worsen the patient's symptoms?
Measured: 1 hour, 24 hours, 48 hours
Patient Tolerability - Insertion Perception Experience (IPE) Perception Experience (IPE)
Patient perception of the chest tube insertion procedure.
- = It was okay, I can tolerate it, I can do it again.
- = It was okay, but I don't want to go through this again.
- = It was a bad experience for me.
- = It was a worse experience for me.
- = It was the worst experience of my life!
Measured: 1 hour
Ease of CLR System Use - Industry-Standard System Usability Scale (SUS)
By physician who used the CLR Irrigator System. 5-point Likert scale from strongly disagree (low) to strongly agree (high).
Measured: 1 hour, 24 hours, 48 hours
Chest Tube Placement Duration
Length of time the chest tube remained in the patient
Measured: Through discharge or 30 days
Length of hospital stay
Length of hospital stay
Measured: Through discharge or 30 days
Aggregate Hospital Charges for Patient Stay
Estimated cost of patient care at hospital
Measured: Through discharge or 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start30 Mar 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemothorax; TraumaticStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- This is a single arm interventional pilot study comparing groups of trauma hemothorax-diagnosed patients. There will be 2 treatment groups and 2 historical control groups.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- CLR Medical
- Responsible party
- Principal investigator, Jeremy Cannon, University of Pennsylvania
- Investigators
- Jeremy Cannon, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06937450
- Sponsor's protocol ID
- 855480
- Acronym
- HTXDLYLAVGE
- Status last verified
- Sep 2026
- First submitted
- 21 Mar 2024
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There is no plan to share Individual Participant Data.
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Traumatic Hemothorax Treatment With 14-Fr Pigtail Catheters or Large Bore (~28Fr) Chest Tubes With Daily Irrigation: A Pilot Single-Arm Intervention Study
- ClinicalTrials.gov ID
- NCT06937450
- Acronym / sponsor ID
- HTXDLYLAVGE / 855480
- Conditions
- Hemothorax; Traumatic
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- CLR Medical
- Study start
- 30 Mar 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 22 Apr 2025 (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.
This HTX treatment study evaluates the effects of chest tube size and the benefits of daily irrigations on acute HTX. 20 acutely injured but stable trauma patients requiring a chest tube for HTX will be enrolled. Patients will be assigned a 28Fr or 14 Fr chest tube with serial lavage and drainage. The endpoints will be HTX volume (by CT scan), complications, additional interventions, hospital length of stay, chest tube duration, provider feedback, and patient-reported outcomes.
Detailed description
This hemothorax (HTX) treatment study will evaluate the effects of chest tube size and daily lavage on HTX management outcomes. A total of 20 stable trauma patients requiring a chest tube for HTX will be recruited and consented. These patients will then undergo either 28Fr or 14Fr chest tube placement, depending on the preference of the treatment team at the time of placement. The study will include 10 patients with each type of chest tube (28Fr and 14Fr). Daily lavage will then be performed at 24h and 48h post-placement. Patients will be compared to historical control patients from the trauma registry who received either 28Fr or 14Fr chest tube placement followed by an initial lavage only. The primary endpoint will be the need for additional interventions such as tPA, additional chest tubes, thoracoscopic surgery (VATS), or thoracotomy. Secondary endpoints will include X-ray appearance at 72 hours, volume of HTX on CT at 72 hours, procedural complications, development of empyema (safety endpoint), development of delayed bleeding (safety endpoint), hospital length of stay, chest tube duration, provider feedback, and patient-reported outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a single arm interventional pilot study comparing groups of trauma hemothorax-diagnosed patients. There will be 2 treatment groups and 2 historical control groups.
| Arm | Type | Receives |
|---|---|---|
| Open 28 Fr Tube Thoracostomy with Daily Lavage and Drainage | Experimental | Device: CLR Irrigator, Procedure: Serial Lavage and Drainage, Device: 28 Fr Open Chest TubeOpen Tube Thoracostomy with Daily Lavage and Drainage |
| Percutaneous 14-Fr Catheter with Daily Lavage and Drainage | Experimental | Device: CLR Irrigator, Procedure: Serial Lavage and Drainage, Device: Percutaneous 14Fr Chest TubePercutaneous 14-Fr Catheter with Daily Lavage and Drainage |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Able to provide consent for the research study
- More than 15 years of age
- Presence of acute traumatic HTX or HTX-PTX diagnosed on chest CT scan within 24 hours of injury and clinical indication for drainage (hemothorax of moderate or large size greater then 300 mL)
- Hemodynamic stability (heart rate 120 beats per minute; systolic blood pressure 90 mmHg)
- Bilateral or unilateral hemothorax of greater than 300 mL HTX by Mergo Formula from chest CT
Key exclusion criteria (5 listed)
- Less than 15 years of Age
- Prisoner
- Pregnant due to the risk of CT scans
- HTX or HTX-PTX not requiring drainage or drainage performed prior to randomization/enrollment
- Patients undergoing operative intervention (i.e. thoracotomy) as initial management of hemothorax (6) Persistent hemodynamic instability after initial resuscitation and CT imaging
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 |
|---|---|---|
| CLR IrrigatorAll enrolled patients will have their hemothorax treated with a CLR device that allows for easy suction and irrigation through indwelling catheters, | Device | Open 28 Fr Tube Thoracostomy with Daily Lavage and Drainage, Percutaneous 14-Fr Catheter with Daily Lavage and Drainage |
| Serial Lavage and DrainageThe current protocol is to do a singular lavage and drainage, this study will investigate the benefits of daily lavage. | Procedure or surgery | Open 28 Fr Tube Thoracostomy with Daily Lavage and Drainage, Percutaneous 14-Fr Catheter with Daily Lavage and Drainage |
| 28 Fr Open Chest TubePatients will have a standard 28 Fr open chest tube or a percutaneous 14Fr chest tube placed. | Device | Open 28 Fr Tube Thoracostomy with Daily Lavage and Drainage |
| Percutaneous 14Fr Chest TubePatients will have a standard 28 Fr open chest tube, or a percutaneous 14Fr chest tube placed. | Device | Percutaneous 14-Fr Catheter with Daily Lavage and Drainage |
Primary outcome
Remaining Hemothorax Volume at 72 hours
Time frame: 72 hours
Assessed by CT and Mergo Formula
7 secondary outcomes
Number of patients requiring intervention for retained hemothorax (excluding those who require intervention for other treatment)
Time frame: Through hospital discharge or 30 days
Patient Tolerability - Numerical Rating Scale Insertion Perception Experience
Time frame: 1 hour, 24 hours, 48 hours
Patient Tolerability - Insertion Perception Experience (IPE) Perception Experience (IPE)
Time frame: 1 hour
Ease of CLR System Use - Industry-Standard System Usability Scale (SUS)
Time frame: 1 hour, 24 hours, 48 hours
Chest Tube Placement Duration
Time frame: Through discharge or 30 days
Length of hospital stay
Time frame: Through discharge or 30 days
Aggregate Hospital Charges for Patient Stay
Time frame: Through discharge or 30 days
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 11 Sep 2026.
- Individual participant dataSharing planned: No. There is no plan to share Individual Participant Data.
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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.
Jeremy Cannon, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CLR Irrigator, Serial Lavage and Drainage and 28 Fr Open Chest Tube in people with Hemothorax; Traumatic, run by University of Pennsylvania 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 6 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 11 Sep 2026. 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?
Contact Jeremy W Cannon, MD (215-66-27320, jeremy.cannon@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Remaining Hemothorax Volume at 72 hours (time frame: 72 hours). 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 11 Sep 2026.