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NCT01828749 · ClinicalTrials.gov registry record

Pelvic CT Imaging in Blunt Abdominal Trauma

A clinical trial of Blunt Abdominal Trauma, sponsored by Wake Forest University Health Sciences.

Completed
Registry status
230
Enrollment target
1
Study location

NCT01828749: Completed study of Blunt Abdominal Trauma, sponsored by Wake Forest University Health Sciences.

NCT01828749 is a study of Blunt Abdominal Trauma that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 230 participants. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01828749, a study of Blunt Abdominal Trauma, has completed, sponsored by Wake Forest University Health Sciences.

COMPLETED
Registry status
230 participants
Enrollment target
1
Study location

Study Summary

Abdominopelvic CT (CTap) utilization rose significantly in blunt trauma patients over the last decade. However, the observed increases failed to reduce mortality or missed injury rates. Several investigators have derived (citation) and validated (citation) clinical decision rules that attempt to identify a subset of low risk pediatric and adult patients in whom abdominopelvic CT imaging can be safely eliminated. Thus far these efforts failed to significantly reduce utilization. The investigators propose an alternative and complimentary strategy to decrease radiation by selectively eliminating the pelvic imaging portion of the abdominopelvic CT in low risk patients. In stable, alert patients without clinically evidence of pelvis or hip fractures, abdominal CT imaging alone (diaphragm to iliac crest) identifies clinically significant intra-abdominal injury (cs-IAI) as accurately as routine abdominopelvic imaging (diaphragm to greater trochanter) and results in a clinically important decrease in radiation exposure. The study will investigate this by comparing the accuracy of an imaging protocol using CT abdomen alone versus CT abdomen and pelvis to detect cs-IAI among stable, blunt trauma patients without suspected pelvis or hip fractures in two age groups: ages 3-17 years and 18-60. Patients will undergo CT imaging as deemed clinically indicated by the treating clinician. Among those who have abdominopelvic CT scans, the study will determine the test characteristics of CT abdomen alone versus CT abdomen plus CT pelvis imaging for the identification of cs-IAI. The reference standard will include initial radiology reports, with structured follow up of indeterminate scans, operative reports, and 7-day medical record review.

Primary Outcome

Accuracy of CT abdomen alone versus CT abdomen and pelvis to detect IAI among stable, blunt trauma patients without suspected fractures of the pelvis, hip or lumbar spine will be compared. The original abdominopelvic CT will be used to create matched pairs of de-identified and digitally reformatted CT abdomen and CT abdomen and pelvis studies. A board certified study radiologist, blinded to the original CT reading and clinical outcome, will interpret the digitally reformatted CT abdomen studies

Conditions Studied

Study Locations (1)

North Carolina

  • Carolinas Medical Center - Charlotte

Trial Details

FieldValue
Enrollment Target 230 participants
Start Date 2013-02
Est. Completion 2015-03
Wake Forest University Health Sciences

1,140 total trials

What the finished NCT01828749 record still lists

NCT01828749 is an observational study that tracks outcomes without assigning an intervention. The registered 230 participants enrollment target is mid-sized for trials with a published cap.

The record links to 1 condition, with Blunt Abdominal Trauma appearing as the primary indexed condition, and to 0 interventions.

NCT01828749 reports a single indexed study location in North Carolina.

Frequently Asked Questions

What is clinical trial NCT01828749 about?

NCT01828749 is a clinical study titled "Pelvic CT Imaging in Blunt Abdominal Trauma". Abdominopelvic CT (CTap) utilization rose significantly in blunt trauma patients over the last decade. However, the observed increases failed to reduce mortality or missed injury rates. Several investigators have derived (citation) and validated (citation) clinical decision rules that attempt to ide...

What is the current status of trial NCT01828749?

This trial is currently completed. The enrollment target is 230 participants. The study started on 2013-02. Estimated completion is 2015-03.

What conditions does trial NCT01828749 study?

This clinical trial studies the following conditions: Blunt Abdominal Trauma.

Who is sponsoring clinical trial NCT01828749?

This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01828749 being conducted?

This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT01828749, the US trial registry maintained by the National Library of Medicine. NCT01828749 (mid enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.