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

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of California, Los Angeles
Study ID
NCT04937868
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Jan 15, 2018
Status verified
Jan 2026
Primary completion
Jan 15, 2027
Completion
Jun 15, 2027

Study Design

Enrollment
12,000 participants (estimated)

Arms

  • Arm: 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.

Primary Outcome Measure

Detection of injuries of major clinical significance [ Time Frame: Initial abdominal-pelvic imaging on the 1 day of presentation. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Ronald Reagan HospitalLos AngelesCalifornia90024
William R Mower, MD, PhD
[email protected]
Robert M Rodriguez, MD (PRINCIPAL_INVESTIGATOR)
Ali S Raja, MD, MPH (PRINCIPAL_INVESTIGATOR)
Malkeet Gupta, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Los Angeles, CA

By research site
Ronald Reagan Hospital· Los Angeles, CA

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