NCT04937868 Developing a Decision Instrument to Guide Abdominal-pelvic CT Imaging of Blunt Trauma Patients
| NCT ID | NCT04937868 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, Los Angeles |
| Condition | Abdominal Injury |
| Study Type | OBSERVATIONAL |
| Enrollment | 12,000 participants |
| Start Date | 2018-01-15 |
| Primary Completion | 2027-01-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 12,000 participants in total. It began in 2018-01-15 with a primary completion date of 2027-01-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: Blunt trauma patients who undergo abdominal-pelvic CT imaging during their initial trauma evaluation in the emergency department. Exclusion Criteria: None
Contact & Investigator
William R Mower, MD, PhD
STUDY DIRECTOR
University of California, Los Angeles
Frequently Asked Questions
Who can join the NCT04937868 clinical trial?
This trial is open to participants of all sexes, studying Abdominal Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04937868 currently recruiting?
Yes, NCT04937868 is actively recruiting participants. Contact the research team at wmower@ucla.edu for enrollment information.
Where is the NCT04937868 trial being conducted?
This trial is being conducted at Los Angeles, United States.
Who is sponsoring the NCT04937868 clinical trial?
NCT04937868 is sponsored by University of California, Los Angeles. The principal investigator is William R Mower, MD, PhD at University of California, Los Angeles. The trial plans to enroll 12,000 participants.