Developing a Decision Instrument to Guide Abdominal-pelvic CT Imaging of Blunt Trauma Patients

NCT04937868 | Recruiting

• 1 other identifier: 01APCT
• Study Type: observational
• Target: 12,000
• Locations: 1 country
• Sites: 1

Brief Summary

Unrecognized abdominal and pelvic injuries can result in catastrophic disability and death. Sporadic reports of "occult" injuries have generated concern, and physicians, fearing that they may miss such an injury, have adopted the practice of obtaining computed tomography on virtually all patients with significant blunt trauma. This practice exposes large numbers patients to dangerous radiation at considerable expense, while detecting injuries in a small minority of cases. Existing data suggest that a limited number of criteria can reliably identify blunt injury victims who have "no risk" of abdominal or pelvic injuries, and hence no need for computed tomography (CT), without misidentifying any injured patient. It is estimated that nationwide implementation of such criteria could result in an annual reduction in radiographic charges of $75 million, and a significant decrease in radiation exposure and radiation induced malignancies. This study seeks to determine whether "low risk" criteria can reliably identify patients who have sustained significant abdominal or pelvic injuries and safely decrease CT imaging of blunt trauma patients. This goal will be accomplished in the following manner: All blunt trauma victims undergoing computed tomography of the abdomen/pelvis in the emergency department will undergo routine clinical evaluations prior to radiographic imaging. Based on these examinations, the presence or absence of specific clinical findings (i.e. abdominal/pelvic/flank pain, abdominal/pelvic/flank tenderness, bruising abrasions, distention, hip pain, hematuria, hypotension, tachycardia, low or falling hematocrit, intoxication, altered sensorium, distracting injury, positive FAST imaging, dangerous mechanism, abnormal x-ray imaging) will be recorded for each patient, as will the presence or absence of abdominal or pelvic injuries. The clinical findings will serve as potential imaging criteria. At the completion of the derivation portion of the study the criteria will be examined to find a subset that predicts injury with high sensitivity, while simultaneously excluding injury, and hence the need for imaging, in the remaining patients. These criteria will then be confirmed in a separate validation phase of the study. The criteria will be considered to be reliable if the lower statistical confidence limit for the measured sensitivity exceeds 98.0%. Potential reductions in CT imaging will be estimated by determining the proportion of "low-risk" patients that do not have significant abdominal or pelvic injuries.

Conditions

Genital Hemorrhage; Lumbar Spine Injury; Hip Injuries; Liver Injury; Spleen Injury; Renal Injury; Diaphragm Injury; Aortic Rupture; Aortic Dissection; Bowel Disease; Vascular System Injuries; Sacral Fracture; Abdominal Injury; Pelvic Fracture

Keywords

Blunt trauma; Abdominal injury; Pelvic injury; Spine injury; Genital injury; Vascular injury; Hip injury; Computed tomography; Decision instrument

Outcome Measures

Primary Outcomes (2)

• Detection of injuries of major clinical significance

  Injuries of major clinical significance consist of all abdominal and pelvic injuries requiring intervention, as well as any injury to the aorta, and any injury to the spine involving instability or neurological compromise.

  Initial abdominal-pelvic imaging on the 1 day of presentation.

• Detection of injuries of major or minor clinical importance

  Detect the presences of all abdominal and pelvic injuries requiring intervention or observation, including all abdominal and pelvic injuries requiring intervention, as well as any injury to the aorta, and any injury to the spine involving instability or neurological compromise.

  Initial abdominal-pelvic imaging on the 1 day of presentation.

Study Arms (1)

Blunt trauma patients undergoing abdominopelvic computed tomographic imaging

The study will be observational and not alter the care or management of blunt injury victims. Medical decisions will be made by treating physicians using current standards of care. Thus, to reduce the potential for bias, the study will seek to enroll all blunt injury victims who undergo A/P imaging as part of their ED trauma evaluation. This may include children, the elderly, all races, both sexes, and any other demographic or social groups that may present among blunt injury patients. An individual will become eligible for the study when the treating physician determines that A/P CT imaging is needed for their trauma evaluation. Inclusion or exclusion will not be based on age, gender, pregnancy or child-bearing potential, or racial/ethnic origin. There will be no exclusion criteria.

Other: There are no interventions associated with this study

Interventions

There are no interventions associated with this study OTHER

This study is purely observational, there will be no interventions or changes in care related to patient inclusion in this study.

Blunt trauma patients undergoing abdominopelvic computed tomographic imaging

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All blunt injury victims who undergo A/P imaging as part of their ED trauma evaluation. This may include children, the elderly, all races, both sexes, and any other demographic or social groups that may present among blunt injury patients. An individual will become eligible for the study when the treating physician determines that A/P CT imaging is needed for their trauma evaluation. Inclusion or exclusion will not be based on age, gender, pregnancy or child-bearing potential, or racial/ethnic origin.

You may qualify if:

• Blunt trauma patients who undergo abdominal-pelvic CT imaging during their initial trauma evaluation in the emergency department.

You may not qualify if:

• None

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Brigham and Women's Hospital: collaborator
• University of California, San Francisco: collaborator
• Antelope Valley Hospital: collaborator
• Stanford University: collaborator
• UCSF - Fresno: collaborator
• UC Davis: collaborator

Study Sites (1)

Ronald Reagan Hospital

Los Angeles, California, 90024, United States

RECRUITING

Related Publications (40)

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MeSH Terms

Conditions

Abdominal Injuries; Hip Fractures; Spinal Injuries; Hip Injuries; Aortic Rupture; Aortic Dissection; Intestinal Diseases; Vascular System Injuries; Wounds, Nonpenetrating

Condition Hierarchy (Ancestors)

Wounds and Injuries; Femoral Fractures; Fractures, Bone; Leg Injuries; Back Injuries; Aneurysm, Ruptured; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Aneurysm; Aortic Diseases; Rupture; Dissection, Blood Vessel; Acute Aortic Syndrome; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• William R Mower, MD, PhD

  University of California, Los Angeles

  STUDY DIRECTOR

Central Study Contacts

William R Mower, MD, PhD

CONTACT

(310) 794-0599; wmower@ucla.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Emergency Medicine, David Geffen School of Medicine at UCLA

Study Record Dates

• First Submitted: May 24, 2021
• First Posted: June 24, 2021
• Study Start: January 15, 2018
• Primary Completion (Estimated): January 15, 2027
• Study Completion (Estimated): June 15, 2027
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: We anticipate data will become available in the next two to four years, and will be available for a period of seven years.
• Access Criteria: To be determined

Locations

US (1)