Clinical trial NCT06937450: Traumatic Hemothorax Drainage and Daily Lavage: Pilot 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hemothorax; Traumatic
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: CLR Medical
First posted: 2025-04-22
Enrollment: 20
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

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 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.

Eligibility criteria: Inclusion Criteria:

1. Able to provide consent for the research study
2. More than 15 years of age
3. 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)
4. Hemodynamic stability (heart rate 120 beats per minute; systolic blood pressure 90 mmHg)
5. Bilateral or unilateral hemothorax of greater than 300 mL HTX by Mergo Formula from chest CT
6. Able to complete the entire study including randomization, tube placement, lavages and final CT Scan.

Exclusion Criteria:

1. Less than 15 years of Age
2. Prisoner
3. Pregnant due to the risk of CT scans
4. HTX or HTX-PTX not requiring drainage or drainage performed prior to randomization/enrollment
5. Patients undergoing operative intervention (i.e. thoracotomy) as initial management of hemothorax (6) Persistent hemodynamic instability after initial resuscitation and CT imaging

Primary outcomes:
measure: Remaining Hemothorax Volume at 72 hours
timeFrame: 72 hours
Secondary outcomes:
measure: Number of patients requiring intervention for retained hemothorax (excluding those who require intervention for other treatment)
timeFrame: Through hospital discharge or 30 days
measure: Patient Tolerability - Numerical Rating Scale (NRS) Perception Experience (IPE)
timeFrame: 1 hour, 24 hours, 48 hours
measure: Patient Tolerability - Insertion Perception Experience (IPE) Perception Experience (IPE)
timeFrame: 1 hour
measure: Ease of CLR System Use - Industry-Standard System Usability Scale (SUS)
timeFrame: 1 hour, 24 hours, 48 hours
measure: Chest Tube Placement Duration
timeFrame: Through discharge or 30 days
measure: Length of hospital stay
timeFrame: Through discharge or 30 days
measure: Aggregate Hospital Charges for Patient Stay
timeFrame: Through discharge or 30 days
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Penn Presbyterian Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Jeremy Cannon, MD
role: PRINCIPAL_INVESTIGATOR
References: