Traumatic Hemothorax Drainage and Daily Lavage: Pilot Study

Last updated: April 17, 2025
Sponsor: University of Pennsylvania
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chest Trauma

Treatment

28 Fr Open Chest Tube

Serial Lavage and Drainage

CLR Irrigator

Clinical Study ID

NCT06937450
855480
  • Ages > 15
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 24hours of injury and clinical indication for drainage (hemothorax of moderate orlarge size greater then 300 mL)

  4. Hemodynamic stability (heart rate 120 beats per minute; systolic blood pressure 90mmHg)

  5. Bilateral or unilateral hemothorax of greater than 300 mL HTX by Mergo Formula fromchest CT

  6. Able to complete the entire study including randomization, tube placement, lavagesand final CT Scan.

Exclusion

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 torandomization/enrollment

  5. Patients undergoing operative intervention (i.e. thoracotomy) as initial managementof hemothorax (6) Persistent hemodynamic instability after initial resuscitation andCT imaging

Study Design

Total Participants: 20
Treatment Group(s): 4
Primary Treatment: 28 Fr Open Chest Tube
Phase:
Study Start date:
March 03, 2025
Estimated Completion Date:
August 01, 2027

Study 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.

Connect with a study center

  • Penn Presbyterian Medical Center

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

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