Enrolling by invitationNCT05263765Updated Mar 28, 2024

Aortic Occlusion for Resuscitation in Trauma and Acute Care Surgery

An observational study in Aortic Occlusion, sponsored by Methodist Health System. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2024-03-28.

Sponsored by Methodist Health System · Observational

From the registry’s dates

Primary completion was expected by Dec 2024, 1 year 9 months ago, but the record still lists the study as enrolling by invitation.

Study type: Observational
Model: Case-only
Time perspective: Other
Enrollment: 100
Ages: 18 Years to 100 Years
Sex: All

Study 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.

Read the 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 studied

Aortic Occlusion

In context

Lead sponsor

Methodist Health System is the lead sponsor of 169 studies on the registry; 52 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 100 Years
Sexes eligible: All
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

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

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

Observational model: Case-only
Time perspective: Other
Enrollment: 100 participants (estimated)
Patient registry: No

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.

What researchers measure

Primary outcomes

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

Study locations

1 site

Methodist Dallas Medical Center
Dallas, Texas 75203, United States

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 28, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05263765
Lead sponsor: Methodist Health System
Responsible party: Sponsor
First posted: Mar 3, 2022
Start date: Dec 29, 2022
Primary completion: Dec 29, 2024 (estimated)
Completion: Dec 29, 2024 (estimated)
Last update: Mar 28, 2024

Study contacts

Conner McDaniel, M.D.

principal investigator · Methodist Health System

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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Discussion

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