Aortic Occlusion for Resuscitation in Trauma and Acute Care Surgery

• Conditions: Aortic Occlusion

• Registration Number: NCT05263765
• Lead Sponsor: Methodist Health System

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.

Study Timeline

• Study First Submitted: 2022-02-03
• Study First Submitted QC: 2022-02-21
• Study First Posted: 2022-03-03
• Study Start: 2022-12-29
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-26
• Last Update Posted: 2024-03-28
• Primary Completion: 2024-12-29
• Study Completion: 2024-12-29

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Methodist Dallas Medical Center; 🇺🇸 Dallas, Texas, United States