Status:
RECRUITING
Traumatic Hemothorax Drainage and Daily Lavage: Pilot Study
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
CLR Medical
Conditions:
Hemothorax; Traumatic
Eligibility:
All Genders
15+ years
Phase:
NA
Brief 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 ...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 3 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06937450
Start Date
March 3 2025
End Date
August 1 2027
Last Update
April 22 2025
Active Locations (1)
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1
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, United States, 19104