Aortic Occlusion for Resuscitation in Trauma and Acute Care Surgery

NCT ID: NCT05263765

Last Updated: 2024-03-28

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-12-29
• Study Completion Date: 2024-12-29

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.

Conditions

Aortic Occlusion

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: OTHER

Interventions

utilization 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Methodist Health System

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Conner McDaniel, M.D.

Role: PRINCIPAL_INVESTIGATOR

Methodist Health System

Locations

Methodist Dallas Medical Center

Dallas, Texas, United States

Countries

United States

Other Identifiers

063.TRA.2021.D

Identifier Type: -

Identifier Source: org_study_id