Comparing treatments for traumatic hemothorax management
The Management of Traumatic Hemothoraces in Blunt Thoracic Injured Patients: A Randomized Clinical Trial
This study is testing whether using a chest tube or just waiting to see if treatment is needed is better for patients with stable traumatic hemothorax after a blunt chest injury.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | University of Calgary Academic / other |
| Locations | 2 sites (Calgary, Alberta and 1 other locations) |
| Trial ID | NCT03050502 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the management of traumatic hemothorax (HTX) in patients with blunt thoracic injuries who are hemodynamically stable. It will compare two approaches: chest tube drainage and expectant management, where no immediate intervention is performed. The study is prompted by the uncertainty surrounding the necessity of chest tube placement for small to moderate HTXs, especially given the potential complications associated with this procedure. By conducting a randomized controlled trial, the researchers hope to clarify the optimal treatment strategy for these patients.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with blunt thoracic injuries and CT-detected hemothorax who are stable.
Not a fit: Patients with hemodynamic instability, respiratory distress related to HTX, or those requiring urgent chest tube placement will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to safer management practices for patients with traumatic hemothorax, reducing unnecessary interventions and associated complications.
How similar studies have performed: Previous studies have suggested that small to moderate hemothoraces may be managed without intervention, indicating that this approach is being explored but requires further validation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age \>= 18 years 2. Blunt thoracic injury 3. CT detected hemothorax Exclusion Criteria: 1. Hemodynamic instability that is related to HTX in the judgment of the attending clinician 2. Any scenario where the clinician mandates urgent TT placement 3. Penetrating thoracic injury 4. Respiratory distress that is related to HTX in the judgment of the attending clinician 5. Chest tube already in-situ (eg. Prior to transfer of care to the FMC) 6. \>24 h after admission 7. Ipsilateral flail chest fracture pattern
Where this trial is running
Calgary, Alberta and 1 other locations
- Foothills Medical Centre — Calgary, Alberta, Canada (Recruiting)
- Foothills Medical Centre, Faculty of Medicine — Calgary, Alberta, Canada (Recruiting)
Study contacts
- Principal investigator: Chad G Ball, MD — University of Calgary
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.