Status:
ENROLLING_BY_INVITATION
Aortic Occlusion for Resuscitation in Trauma and Acute Care Surgery
Lead Sponsor:
Methodist Health System
Conditions:
Aortic Occlusion
Eligibility:
All Genders
18-100 years
Brief Summary
Aortic occlusion (AO) for trauma has traditionally been accomplished by supra-diaphragmatic clamping of the descending thoracic aorta via emergent thoracotomy or as an initial step during laparotomy.
Detailed Description
An evolution in endovascular technologies, however, has provided additional means by which to achieve AO. Expanding experience with the utilization of balloon occlusion in the setting of abdominal aor...
Eligibility Criteria
Inclusion
- All adult (age ≥ 18 years) trauma and acute care surgery patients treated with resuscitative AO (via open or endovascular means) in the acute phases after injury
- Transient or refractory hypotension (systolic blood pressure \<90mmHg) with a positive abdominal focused abdominal sonography in trauma (FAST) scan, severe pelvic fracture(s), or neither with persistent hypotension without obvious source
- Chest x-ray without evidence of thoracic aortic injury
- Subject treatment includes internal aortic cross-clamp or would have likely benefited from an internal aortic cross-clamp
Exclusion
- Subject \< 18 years of age
- Prisoner
- Evidence of cardiac, thoracic aortic, or great vessel injury identified in primary survey, FAST scan, and/or x-rays
- Any open/exsanguinating upper extremity wound
Key Trial Info
Start Date :
December 29 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 29 2024
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05263765
Start Date
December 29 2022
End Date
December 29 2024
Last Update
March 28 2024
Active Locations (1)
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1
Methodist Dallas Medical Center
Dallas, Texas, United States, 75203