NCT06937450 · University of Pennsylvania
Traumatic Hemothorax Drainage and Daily Lavage
(HTXDLYLAVGE)
What this study is about
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.
View original scientific description
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.
Interventions
DEVICE
CLR Irrigator
All enrolled patients will have their hemothorax treated with a CLR device that allows for easy suction and irrigation through indwelling catheters,
PROCEDURE
Serial Lavage and Drainage
The current protocol is to do a singular lavage and drainage, this study will investigate the benefits of daily lavage.
DEVICE
28 Fr Open Chest Tube
Patients will have a standard 28 Fr open chest tube or a percutaneous 14Fr chest tube placed.
DEVICE
Percutaneous 14Fr Chest Tube
Patients will have a standard 28 Fr open chest tube, or a percutaneous 14Fr chest tube placed.
Primary outcome measures
Remaining Hemothorax Volume at 72 hours
Time frame: 72 hours
Assessed by CT and Mergo Formula
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- Less than 15 years of Age
- 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
Where
- Philadelphia, Pennsylvania
Collaborators
CLR Medical
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 18, 2026 · Source of record for eligibility and locations