An interventional study of CLR Irrigator and Serial Lavage and Drainage in Hemothorax; Traumatic, sponsored by University of Pennsylvania. Recruiting at 1 site in United States. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by University of Pennsylvania · Not applicable, Interventional, and Treatment
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.
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.
26 studies on the registry are indexed under Hemothorax; 5 are open to participants now.
This study's planned enrollment of 20 is below the median of 100 across 21 interventional studies indexed under Hemothorax.
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Exclusion Criteria:
Open Tube Thoracostomy with Daily Lavage and Drainage
Device: CLR Irrigator · Procedure: Serial Lavage and Drainage · Device: 28 Fr Open Chest Tube
Percutaneous 14-Fr Catheter with Daily Lavage and Drainage
Device: CLR Irrigator · Procedure: Serial Lavage and Drainage · Device: Percutaneous 14Fr Chest Tube
All enrolled patients will have their hemothorax treated with a CLR device that allows for easy suction and irrigation through indwelling catheters,
The current protocol is to do a singular lavage and drainage, this study will investigate the benefits of daily lavage.
Patients will have a standard 28 Fr open chest tube or a percutaneous 14Fr chest tube placed.
Patients will have a standard 28 Fr open chest tube, or a percutaneous 14Fr chest tube placed.
Remaining Hemothorax Volume at 72 hours
Assessed by CT and Mergo Formula
Time frame: 72 hours
Number of patients requiring intervention for retained hemothorax (excluding those who require intervention for other treatment)
All interventions focused on resolving any remaining hemothorax
Time frame: 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?
Time frame: 1 hour, 24 hours, 48 hours
Patient Tolerability - Insertion Perception Experience (IPE) Perception Experience (IPE)
Patient perception of the chest tube insertion procedure. 1. = It was okay, I can tolerate it, I can do it again. 2. = It was okay, but I don't want to go through this again. 3. = It was a bad experience for me. 4. = It was a worse experience for me. 5. = It was the worst experience of my life!
Time frame: 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).
Time frame: 1 hour, 24 hours, 48 hours
Chest Tube Placement Duration
Length of time the chest tube remained in the patient
Time frame: Through discharge or 30 days
Length of hospital stay
Length of hospital stay
Time frame: Through discharge or 30 days
Aggregate Hospital Charges for Patient Stay
Estimated cost of patient care at hospital
Time frame: Through discharge or 30 days
Plan to share: No — There is no plan to share Individual Participant Data.
No publications or documents are linked to this record.
Started Mar 2025 (actual). Primary completion is estimated for Dec 2026, 21 months after the start.
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