Aortic Occlusion for Resuscitation in Trauma and Acute Care Surgery

NCT05263765 | Enrolling By Invitation

• 1 other identifier: 063.TRA.2021.D
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Occlusion

Outcome Measures

Primary Outcomes (7)

• 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 Data

  Mechanism classification - Penetrating, Blunt or Non-trauma Hemorrhage

  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

Interventions

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

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

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Methodist Health System: lead

Study Sites (1)

Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

Location

Study Officials

• Conner McDaniel, M.D.

  Methodist Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2022
• First Posted: March 3, 2022
• Study Start: December 29, 2022
• Primary Completion: December 29, 2024
• Study Completion: December 29, 2024
• Last Updated: March 28, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)