Traumatic Hemothorax Drainage and Daily Lavage

NCT06937450 | Recruiting FDA Device

• 1 other identifier: 855480
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Remaining Hemothorax Volume at 72 hours

  Assessed by CT and Mergo Formula

  72 hours

Secondary Outcomes (7)

• Number of patients requiring intervention for retained hemothorax (excluding those who require intervention for other treatment)

  Through hospital discharge or 30 days

• Patient Tolerability - Numerical Rating Scale Insertion Perception Experience

  1 hour, 24 hours, 48 hours

• Patient Tolerability - Insertion Perception Experience (IPE) Perception Experience (IPE)

  1 hour

• Ease of CLR System Use - Industry-Standard System Usability Scale (SUS)

  1 hour, 24 hours, 48 hours

• Chest Tube Placement Duration

  Through discharge or 30 days

Study Arms (2)

Open 28 Fr Tube Thoracostomy with Daily Lavage and Drainage

EXPERIMENTAL

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

EXPERIMENTAL

Percutaneous 14-Fr Catheter with Daily Lavage and Drainage

Device: CLR Irrigator; Procedure: Serial Lavage and Drainage; Device: Percutaneous 14Fr Chest Tube

Interventions

CLR Irrigator DEVICE

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

Open 28 Fr Tube Thoracostomy with Daily Lavage and Drainage; Percutaneous 14-Fr Catheter with Daily Lavage and Drainage

Serial Lavage and Drainage PROCEDURE

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

Open 28 Fr Tube Thoracostomy with Daily Lavage and Drainage; Percutaneous 14-Fr Catheter with Daily Lavage and Drainage

28 Fr Open Chest Tube DEVICE

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

Open 28 Fr Tube Thoracostomy with Daily Lavage and Drainage

Percutaneous 14Fr Chest Tube 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

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Pennsylvania: lead
• CLR Medical: collaborator

Study Sites (1)

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Hemothorax

Interventions

Drainage

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Surgical Procedures, Operative

Study Officials

• Jeremy Cannon, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeremy W Cannon, MD

CONTACT

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

Phillp Kemp Bohan, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Trauma Program Medical Director and Section Chief of Trauma

Model Details: 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.

Study Record Dates

• First Submitted: March 21, 2024
• First Posted: April 22, 2025
• Study Start: March 3, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)