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NCT Number: NCT06937450

Traumatic Hemothorax Drainage and Daily Lavage

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.

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Key information

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

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,

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.

28 Fr Open Chest Tube

Device

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

Percutaneous 14Fr Chest Tube

Device

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

Primary outcomes

  1. Remaining Hemothorax Volume at 72 hours

    Time frame: 72 hours

    Assessed by CT and Mergo Formula

Secondary outcomes

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

    Time frame: Through hospital discharge or 30 days

    All interventions focused on resolving any remaining hemothorax

  2. Patient Tolerability - Numerical Rating Scale Insertion Perception Experience

    Time frame: 1 hour, 24 hours, 48 hours

    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?

  3. Patient Tolerability - Insertion Perception Experience (IPE) Perception Experience (IPE)

    Time frame: 1 hour

    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!
  4. Ease of CLR System Use - Industry-Standard System Usability Scale (SUS)

    Time frame: 1 hour, 24 hours, 48 hours

    By physician who used the CLR Irrigator System. 5-point Likert scale from strongly disagree (low) to strongly agree (high).

  5. Chest Tube Placement Duration

    Time frame: Through discharge or 30 days

    Length of time the chest tube remained in the patient

  6. Length of hospital stay

    Time frame: Through discharge or 30 days

    Length of hospital stay

  7. Aggregate Hospital Charges for Patient Stay

    Time frame: Through discharge or 30 days

    Estimated cost of patient care at hospital

Study contacts

Contact information is provided by the study sponsor or research team.

Jeremy W Cannon, MD

CONTACT

[email protected]

215-66-27320

Phillp Kemp Bohan, MD

CONTACT

[email protected]

267-909-3573

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • CLR Medical

Registry information

Official study title

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

Acronym: HTXDLYLAVGE

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Apr 22, 2025
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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