Aortic Occlusion for Resuscitation in Trauma and Acute Care Surgery

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Aortic Occlusion
• Intervention / Treatment: Procedure: utilization of AO in the acute resuscitation of trauma and acute care surgery patients in shock.

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.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75203
      • Methodist Dallas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographics	Age in years	01 July 2015 through 31st December 2024
Demographics- Gender	Male or Female	01 July 2015 through 31st December 2024
Demographics-Height	Height measured in Inches	01 July 2015 through 31st December 2024
Demographics- Weight	Weight measured in pounds	01 July 2015 through 31st December 2024
Injury Mechanism Type	Gunshot wound, Motor vehicle accident, stab wound, fall	01 July 2015 through 31st December 2024
Body Region	Head/Neck, Chest, Abdomen, pelvis or Extremities	01 July 2015 through 31st December 2024
Injury Data	Mechanism classification - Penetrating, Blunt or Non-trauma Hemorrhage	01 July 2015 through 31st December 2024

Collaborators and Investigators

• Sponsor: Methodist Health System
• Investigators: Principal Investigator: Conner McDaniel, M.D., Methodist Health System

Study record dates

Study Major Dates

• Study Start (Actual): December 29, 2022
• Primary Completion (Estimated): December 29, 2024
• Study Completion (Estimated): December 29, 2024

Study Registration Dates

• First Submitted: February 3, 2022
• First Submitted That Met QC Criteria: February 21, 2022
• First Posted (Actual): March 3, 2022

Study Record Updates

• Last Update Posted (Actual): March 28, 2024
• Last Update Submitted That Met QC Criteria: March 26, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 063.TRA.2021.D

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No