Traumatic Hemothorax Drainage and Daily Lavage (HTXDLYLAVGE)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hemothorax; Traumatic
• Intervention / Treatment: Device: CLR Irrigator; Procedure: Serial Lavage and Drainage; Device: 28 Fr Open Chest Tube; Device: Percutaneous 14Fr Chest Tube

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jeremy W Cannon, MD; Phone Number: 215-66-27320; Email: jeremy.cannon@pennmedicine.upenn.edu
• Study Contact Backup: Name: Phillp Kemp Bohan, MD; Phone Number: 267-909-3573; Email: Phillip.Kempbohn@Pennmedicine.upenn.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • Penn Presbyterian Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Open 28 Fr Tube Thoracostomy with Daily Lavage and Drainage; Open Tube Thoracostomy with Daily Lavage and Drainage	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.
Experimental: Percutaneous 14-Fr Catheter with Daily Lavage and Drainage	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: Percutaneous 14Fr Chest Tube; Patients will have a standard 28 Fr open chest tube, or a percutaneous 14Fr chest tube placed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Remaining Hemothorax Volume at 72 hours	Assessed by CT and Mergo Formula	72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients requiring intervention for retained hemothorax (excluding those who require intervention for other treatment)	All interventions focused on resolving any remaining hemothorax	Through hospital discharge or 30 days
Patient Tolerability - Insertion Perception Experience (IPE) Perception Experience (IPE)	Patient perception of the chest tube insertion procedure.; = It was okay, I can tolerate it, I can do it again.; = It was okay, but I don't want to go through this again.; = It was a bad experience for me.; = It was a worse experience for me.; = It was the worst experience of my life!	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).	1 hour, 24 hours, 48 hours
Chest Tube Placement Duration	Length of time the chest tube remained in the patient	Through discharge or 30 days
Length of hospital stay	Length of hospital stay	Through discharge or 30 days
Aggregate Hospital Charges for Patient Stay	Estimated cost of patient care at hospital	Through 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?	1 hour, 24 hours, 48 hours

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: CLR Medical
• Investigators: Principal Investigator: Jeremy Cannon, MD, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: March 21, 2024
• First Submitted That Met QC Criteria: April 17, 2025
• First Posted (Actual): April 22, 2025

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Hemorrhage; Pleural Diseases; Pathological Conditions, Signs and Symptoms; Hemothorax; Therapeutics; Surgical Procedures, Operative; Drainage
• Other Study ID Numbers: 855480

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to share Individual Participant Data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes