Recruiting

Observational Study

Sponsor:

University of Pennsylvania

Code:

NCT06937450

Conditions

Hemothorax; Traumatic

Eligibility Criteria

Sex: All

Age: 15+

Healthy Volunteers: Not accepted

Interventions

CLR Irrigator

Serial Lavage and Drainage

28 Fr Open Chest Tube

Percutaneous 14Fr Chest Tube

Study Details

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.

Conditions

Hemothorax; Traumatic

Study ID

NCT06937450

Start date

Mar 30, 2025

Status verified date

Jun, 2026

Completion date

Aug 1, 2027

Anticipated

Primary completion date

Aug 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 15+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Open 28 Fr Tube Thoracostomy with Daily Lavage and Drainage

Open Tube Thoracostomy with Daily Lavage and Drainage

experimental: Percutaneous 14-Fr Catheter with Daily Lavage and Drainage

Percutaneous 14-Fr Catheter with Daily Lavage and Drainage

Interventions

CLR Irrigator

All enrolled patients will have their hemothorax treated with a CLR device that allows for easy suction and irrigation through indwelling catheters,

Serial Lavage and Drainage

The current protocol is to do a singular lavage and drainage, this study will investigate the benefits of daily lavage.

28 Fr Open Chest Tube

Patients will have a standard 28 Fr open chest tube or a percutaneous 14Fr chest tube placed.

Percutaneous 14Fr Chest Tube

Patients will have a standard 28 Fr open chest tube, or a percutaneous 14Fr chest tube placed.

Primary outcome measure

  • Remaining Hemothorax Volume at 72 hours [ Time Frame: 72 hours ]

Central Contacts and Locations

Central contacts

Jeremy W Cannon, MD

215-66-27320jeremy.cannon@pennmedicine.upenn.edu

Phillp Kemp Bohan, MD

267-909-3573Phillip.Kempbohn@Pennmedicine.upenn.edu

Locations

Penn Presbyterian Medical Center

Recruiting

Philadelphia, Pennsylvania, United States, 19104

More Information

Sponsor

University of Pennsylvania

Last update posted

Jun 18, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Pennsylvania on 2026-06-18.