Traumatic Hemothorax Drainage and Daily Lavage: Pilot Study

NCT ID: NCT06937450

Last Updated: 2025-04-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-03
• Study Completion Date: 2027-08-01

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.

Conditions

Hemothorax; Traumatic

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Open 28 Fr Tube Thoracostomy with Daily Lavage and Drainage

Open Tube Thoracostomy with Daily Lavage and Drainage

Group Type: EXPERIMENTAL

CLR Irrigator

Intervention Type: DEVICE

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

Intervention Type: PROCEDURE

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

Intervention Type: DEVICE

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

Percutaneous 14-Fr Catheter with Daily Lavage and Drainage

Percutaneous 14-Fr Catheter with Daily Lavage and Drainage

Group Type: EXPERIMENTAL

CLR Irrigator

Intervention Type: DEVICE

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

Intervention Type: PROCEDURE

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

Percutaneous 14Fr Chest Tube

Intervention Type: DEVICE

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

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,

Intervention Type: DEVICE

Serial Lavage and Drainage

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

Intervention Type: PROCEDURE

28 Fr Open Chest Tube

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

Intervention Type: DEVICE

Percutaneous 14Fr Chest Tube

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CLR Medical

UNKNOWN

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Jeremy Cannon

Trauma Program Medical Director and Section Chief of Trauma

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jeremy Cannon, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jeremy W Cannon, MD

Role: CONTACT

jeremy.cannon@pennmedicine.upenn.edu

215-66-27320

Phillp Kemp Bohan, MD

Role: CONTACT

Phillip.Kempbohn@Pennmedicine.upenn.edu

267-909-3573

Other Identifiers

855480

Identifier Type: -

Identifier Source: org_study_id