About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial 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.
Trial design
Cohort
Prospective
Treatments tested in this trial
There are no interventions associated with this study
Other interventionThis study is purely observational, there will be no interventions or changes in care related to patient inclusion in this study.
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
Sponsors and contacts
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University of California, Los Angeles
Lead sponsor
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