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Aortic Occlusion for Resuscitation in Trauma and Acute Care Surgery

Aortic Occlusion for Resuscitation in Trauma and Acute Care Surgery (AORTA)

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05263765
Enrollment
100
Registered
2022-03-03
Start date
2022-12-29
Completion date
2024-12-29
Last updated
2024-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Occlusion

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 aortic rupture due to chronic vascular disease has demonstrated the potential of these new technologies. Discussion of the employment of endovascular AO in the realm of trauma has led to the description of this approach and the demonstration of its effectiveness in animal models of severe hemorrhage. The purpose of the present study is to prospectively examine the modern utilization of AO in the acute resuscitation of trauma and acute care surgery patients in shock.

Interventions

PROCEDUREutilization of AO in the acute resuscitation of trauma and acute care surgery patients in shock.

AO to facilitate the acute resuscitation of trauma and acute care surgery patients in shock.

Sponsors

Methodist Health System
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years

Inclusion criteria

* 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 criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Demographics01 July 2015 through 31st December 2024Age in years
Demographics- Gender01 July 2015 through 31st December 2024Male or Female
Demographics-Height01 July 2015 through 31st December 2024Height measured in Inches
Demographics- Weight01 July 2015 through 31st December 2024Weight measured in pounds
Injury Data01 July 2015 through 31st December 2024Mechanism classification - Penetrating, Blunt or Non-trauma Hemorrhage
Injury Mechanism Type01 July 2015 through 31st December 2024Gunshot wound, Motor vehicle accident, stab wound, fall
Body Region01 July 2015 through 31st December 2024Head/Neck, Chest, Abdomen, pelvis or Extremities

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026