Thoracic Injuries Clinical Trial
— HemoTxRCTOfficial title:
The Management of Traumatic Hemothoraces in Blunt Thoracic Injured Patients: A Randomized Clinical Trial
Verified date | February 2023 |
Source | University of Calgary |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Chest injuries are common in patients with polytrauma and are responsible for approximate 25% of all trauma-related mortalities. Traumatic injuries to the thorax often result in the accumulation of blood within the chest (i.e. a hemothorax (HTX)). The management of HTX remains a clinical dilemma when the volume of blood is small to moderate and the patient is hemodynamically stable. The East American Association of Trauma guidelines suggest that all HTXs should be considered for chest tube drainage. However, a prospective observational study suggested small to moderate HTXs could be absorbed without intervention. Although HTXs are effectively managed with chest tube drainage of the blood (i.e. tube thoracostomy), this intervention is associated with numerous potential major complications, including injury and infection in up to 22% of patients. The purpose of this study is therefore to conduct a randomized controlled study to compare patients with traumatic HTX managed by chest tube drain or expectant management (close monitoring), to determine when a chest tube is needed and when it is not to treat hemothoraces. The results from this study will inform the care of future trauma patients who present with this common injury throughout the globe.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | December 2025 |
Est. primary completion date | March 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | Foothills Medical Centre | Calgary | Alberta |
Canada | Foothills Medical Centre, Faculty of Medicine | Calgary | Alberta |
Lead Sponsor | Collaborator |
---|---|
University of Calgary | Alberta Health services |
Canada,
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DuBose J, Inaba K, Okoye O, Demetriades D, Scalea T, O'Connor J, Menaker J, Morales C, Shiflett T, Brown C, Copwood B; AAST Retained Hemothorax Study Group. Development of posttraumatic empyema in patients with retained hemothorax: results of a prospectiv — View Citation
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Wells BJ, Roberts DJ, Grondin S, Navsaria PH, Kirkpatrick AW, Dunham MB, Ball CG. To drain or not to drain? Predictors of tube thoracostomy insertion and outcomes associated with drainage of traumatic hemothoraces. Injury. 2015 Sep;46(9):1743-8. doi: 10.1 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The numbers of hemothoraces that require thoracic interventions. | The rate of hemothoraces that require thoracic interventions in patients of both groups. | 1 year after patient recruited in the study | |
Secondary | The days of mechanical ventilation in intensive care unit | The median length of days of mechanical ventilation needed by the patients in both groups | 30 days after patients recruited in the study | |
Secondary | The days of intensive care unit stay | The median length of days in ICU needed by patients in both groups | 30 days after patients recruited in the study |
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