Blunt Injury Clinical Trial
— TEVAROfficial title:
Thoracic Endovascular Repair Versus Open Surgery for Blunt Injury
Verified date | September 2016 |
Source | Scripps Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
This study aims to increase understanding of the short-term and long-term outcome of blunt
aortic injury (BAI) and to discern if there is an advantage resulting from the type of
operative treatment used to manage it, either the classic open surgical repair or a newer
technique known as thoracic endovascular repair (TEVAR). Specifically, this study will
answer the following questions regarding patients suffering BAI:
1. What clinical variables affect short-term mortality and neurologic outcome?
2. What are the long-term treatment-associated complications of open repair and TEVAR?
3. In patients with a similar injury and physiologic profile, is there a survival
advantage resulting from the type of operative treatment?
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | December 2016 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Clinical diagnosis of blunt aortic injury (BAI) Exclusion Criteria: - Clinical diagnosis of penetrating aortic injury |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Scripps Mercy Hospital | San Diego | California |
Lead Sponsor | Collaborator |
---|---|
Scripps Health | Western Trauma Association |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Short-Term Mortality | Cause of death during the index hospitalization (prior to discharge, averaging less than 30 days from the time of injury) will be assessed, as measured by death certificate and autopsy or, if no autopsy, morbidity and mortality review findings. Care withdrawn at request of family will also be noted. Final adjudication of mortality (preventable, non-preventable, or possibly preventable)will be gathered. | During the index hospitalization, an expected average of 30 days from time of injury | No |
Secondary | Short-Term Treatment-Associated Complications | Complications during the index hospitalization (prior to discharge, averaging less than 30 days from time of injury) related specifically to TEVAR or to open repair will be gathered. TEVAR-specific complications to include: endoleak; endocollapse; migration; loss of apposition at proximal landing zone; access complications. Open repair-specific complications to include: VATS for retained hemothorax; empyema. | During the index hospitalization, an expected average of 30 days from time of injury | No |
Secondary | Long-Term Treatment-Associated Complications | Complications during the 5-year follow-up period post-discharge, related specifically to TEVAR or to open repair will also be gathered. TEVAR-specific complications to include: endoleak; endocollapse; migration; loss of apposition at proximal landing zone; graft infection; wound infection. Open repair-specific complications to include: graft infection; pseudoaneurysm; wound infection. | Up to 5 years following discharge | No |
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