NCT06937450

Traumatic Hemothorax Drainage and Daily Lavage: Pilot Study

Traumatic Hemothorax Treatment With 14-Fr Pigtail Catheters or Large Bore (~28Fr) Chest Tubes With Daily Irrigation: A Pilot Single-Arm Intervention Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hemothorax; Traumatic

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-03-03
• Primary completion: 2026-08-01
• Completion: 2027-08-01
• First posted: 2025-04-22
• Last updated: 2025-04-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study