Blunt Abdominal TraumaNCT01828749
Pelvic CT Imaging in Blunt Abdominal Trauma
An observational study of Blunt Abdominal Trauma, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 60 years
- Conditions the study is for
- Blunt Abdominal Trauma
- How many people
- 230 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Mar 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: 3-60 years of age evaluated for blunt trauma with a GCS of >14 Order of CT abdomen and pelvis imaging
Who may be able to join
- 3-60 years of age evaluated for blunt trauma with a GCS of >14
- Order of CT abdomen and pelvis imaging
Who cannot join
- Patients requiring intubation or suspected neurological injury (defined above)
- Pregnant patients
- Intoxicated patients
- Patients with age defined hypotension
- Exploratory laparotomy or transfusion during the ED evaluation
- Non-verbal patients
Show all 11Show fewer
- Positive FAST exam
- Patients with abdominal trauma or surgery in the last month
- Victims of sexual assault or non-accidental trauma (NAT)
- Patients with known or suspected fractures of the femur or pelvis prior to CT imaging
- Patients with hip dislocations
Trial locations and contacts
1 site in 1 country.
United States1 site
Carolinas Medical Center
Charlotte, North Carolina, 28210
About this study
Official title: Pelvic CT Imaging in Blunt Trauma: Limiting Low Yield Radiation Exposure in Carefully Selected Adult and Pediatric Patients
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.
Read the detailed description
Abdominopelvic computed tomography (CTap) utilization rose significantly in blunt trauma patients over the last decade but failed to reduce mortality or missed injury rates.
Primary Hypothesis: In stable, alert patients (GCS > 14) without clinically evident fractures of the pelvis, hip or lumbar spine, CT abdomen (CTa) alone (diaphragm to iliac crest) identifies intra-abdominal injury (IAI) with an accuracy that is not inferior to routine CTap (diaphragm to greater trochanter) with a clinically relevant reduction in radiation exposure.
Primary Aim: Compare the accuracy of CTa alone versus CTap to detect IAI in two age groups: ages 3-17 years and 18-60 years. Blunt trauma patients requiring CTap will be enrolled. Data obtained prior to CT imaging include demographics, injury mechanism, exam and pelvic radiograph findings and FAST results from the trauma evaluation. The original CTap will be digitally reformatted to create matched pairs of de-identified CTa and CTap studies. A board certified study radiologist, blinded to the original CT and clinical outcome, will interpret the CTa studies in injured patients. McNemar's chi-square test will be used to evaluate the null hypothesis for injuries in matched pairs assuming no difference for uninjured patients. Te the test characteristics of the CTa versus CTap will be determined. The reference standard will include initial radiology reports, operative reports, and 7-day medical record review. If the upper limit of the 95% confidence interval for the difference in the performance (accuracy) of CTap and CTa alone is less than 3%, the conclusion will be that CTa alone is not inferior to CTap to diagnose IAI. Secondary Aims: The mean effective doses of radiation will be calculated and compared with reductions up to 50% expected. The study will determine if physicians' pretest probability accurately identifies clinically significant pelvis, hip and lumbar spine fractures (CTp indications) in two age groups: ages 3-17 years and 18-60 years. Using a gestalt pretest probability of ≤ 2% as "negative for injury", and a pretest probability > 2% as "positive for injury", the test characteristics of physician estimation will be determined. The test characteristics and interobserver agreement (Cohen's kappa statistic) of exam findings expected to predict fractures of the pelvis, hip and lumbar spine will be reported separately.
- Conditions
- Blunt Abdominal Trauma
- Keywords
- blunt abdominal trauma, CT, radiation exposure, pediatric
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CT abdomen and pelvis | blunt trauma patients without suspected fractures of the pelvis, hip or lumbar spine in two age groups: ages 3-17 years and 18-60 years |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intrabdominal Injury
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 in all injured patients. McNemar's chi-square test will be used to evaluate the null hypothesis for the percentage of correctly identified injuries in the matched pairs assuming no difference for uninjured patients. The sensitivity, specificity and accuracy of the CT abdomen alone versus CT abdomen and pelvis will be determined. The reference standard will include initial radiology reports, with structured follow up of indeterminate scans, operative reports, and 7-day medical record review.
Measured: 7 days
Secondary outcomes (2)
Radiation Exposure
The radiation exposure for imaging protocols of the CT abdomen alone versus CT abdomen and pelvis for study patients in two age groups will be compared: ages 3-17 years and 18-60 years. Using the reported volume CT dose index (CTDI vol), scan length and age specific coefficients for the abdomen/pelvis region of the body, the mean effective radiation doses for CT abdomen alone versus CT abdomen and pelvis will be calculated and compared.
Measured: 7 days
physicians' pretest probability
Determine if physicians' pretest probability accurately identifies clinically significant pelvis, hip and lumbar spine fractures (clinical indications for CT pelvis) in study patients in two age groups: ages 3-17 years and 18-60 years. Using a gestalt pretest probability of ≤ 2% as "negative for injury", and a pretest probability > 2% as "positive for injury", the test characteristics of physician estimation will be determined. The test characteristics and interobserver agreement (Cohen's kappa statistic) of the physical examination findings known to predict fractures of the pelvis, hip and lumbar spine in alert, stable patients for each age group will be reported separately.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2013 (estimated)
- Study startFeb 2013
- Primary completionNov 2013
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blunt Abdominal TraumaStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stacy Reynolds, MD, Principal investigator, Carolinas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01828749
- Sponsor's protocol ID
- 02-13-19E
- Status last verified
- Dec 2015
- First submitted
- 13 Mar 2013
- Last updated
- 25 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pelvic CT Imaging in Blunt Trauma: Limiting Low Yield Radiation Exposure in Carefully Selected Adult and Pediatric Patients
- ClinicalTrials.gov ID
- NCT01828749
- Acronym / sponsor ID
- 02-13-19E
- Conditions
- Blunt Abdominal Trauma
- Keywords
- blunt abdominal trauma, CT, radiation exposure, pediatric
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 11 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Abdominopelvic computed tomography (CTap) utilization rose significantly in blunt trauma patients over the last decade but failed to reduce mortality or missed injury rates.
Primary Hypothesis: In stable, alert patients (GCS > 14) without clinically evident fractures of the pelvis, hip or lumbar spine, CT abdomen (CTa) alone (diaphragm to iliac crest) identifies intra-abdominal injury (IAI) with an accuracy that is not inferior to routine CTap (diaphragm to greater trochanter) with a clinically relevant reduction in radiation exposure.
Primary Aim: Compare the accuracy of CTa alone versus CTap to detect IAI in two age groups: ages 3-17 years and 18-60 years. Blunt trauma patients requiring CTap will be enrolled. Data obtained prior to CT imaging include demographics, injury mechanism, exam and pelvic radiograph findings and FAST results from the trauma evaluation. The original CTap will be digitally reformatted to create matched pairs of de-identified CTa and CTap studies. A board certified study radiologist, blinded to the original CT and clinical outcome, will interpret the CTa studies in injured patients. McNemar's chi-square test will be used to evaluate the null hypothesis for injuries in matched pairs assuming no difference for uninjured patients. Te the test characteristics of the CTa versus CTap will be determined. The reference standard will include initial radiology reports, operative reports, and 7-day medical record review. If the upper limit of the 95% confidence interval for the difference in the performance (accuracy) of CTap and CTa alone is less than 3%, the conclusion will be that CTa alone is not inferior to CTap to diagnose IAI. Secondary Aims: The mean effective doses of radiation will be calculated and compared with reductions up to 50% expected. The study will determine if physicians' pretest probability accurately identifies clinically significant pelvis, hip and lumbar spine fractures (CTp indications) in two age groups: ages 3-17 years and 18-60 years. Using a gestalt pretest probability of ≤ 2% as "negative for injury", and a pretest probability > 2% as "positive for injury", the test characteristics of physician estimation will be determined. The test characteristics and interobserver agreement (Cohen's kappa statistic) of exam findings expected to predict fractures of the pelvis, hip and lumbar spine will be reported separately.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CT abdomen and pelvis | – | –blunt trauma patients without suspected fractures of the pelvis, hip or lumbar spine in two age groups: ages 3-17 years and 18-60 years |
Who may qualify
- Ages
- 3 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- 3-60 years of age evaluated for blunt trauma with a GCS of >14 Order of CT abdomen and pelvis imaging
Key inclusion criteria (2 listed)
- 3-60 years of age evaluated for blunt trauma with a GCS of >14
- Order of CT abdomen and pelvis imaging
Key exclusion criteria (11 listed)
- Patients requiring intubation or suspected neurological injury (defined above)
- Pregnant patients
- Intoxicated patients
- Patients with age defined hypotension
- Exploratory laparotomy or transfusion during the ED evaluation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Intrabdominal Injury
Time frame: 7 days
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 in all injured patients. McNemar's chi-square test will be used to evaluate the null hypothesis for the percentage of correctly identified injuries in the matched pairs assuming no difference for uninjured patients. The sensitivity, specificity and accuracy of the CT abdomen alone versus CT abdomen and pelvis will be determined. The reference standard will include initial radiology reports, with structured follow up of indeterminate scans, operative reports, and 7-day medical record review.
2 secondary outcomes
Radiation Exposure
Time frame: 7 days
physicians' pretest probability
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stacy Reynolds, MD principal investigator
Carolinas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blunt Abdominal Trauma, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intrabdominal Injury (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2022.