<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02206698</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00030071</org_study_id>
    <nct_id>NCT02206698</nct_id>
  </id_info>
  <brief_title>Pediatric Blunt Abdominal Trauma Clinical Prediction Model</brief_title>
  <official_title>Multicenter, Prospective Development of a Clinical Prediction Model to Determine Which Children Can Safely Avoid Abdominal CT Scanning During the Initial Evaluation of Blunt Abdominal Trauma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of South Carolina</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Monroe Carell Jr. Children's Hospital at Vanderbilt</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Arkansas</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Alabama at Birmingham</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Virginia Commonwealth University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Children's Mercy Hospital Kansas City</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Tennessee</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Memorial Hermann Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Baylor College of Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Children's Hospital Los Angeles</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Children's Hospital Medical Center, Cincinnati</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Washington University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Boston Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Emory University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Medical University of South Carolina</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The submitted proposal is designed to reduce morbidity and mortality to injured children.&#xD;
      Significant variability in the initial trauma assessment exists among institutions. The&#xD;
      proposed project is a prospective, observational, multi-institutional study of children&#xD;
      following blunt abdominal trauma. The specific goals of the project are to: 1) Document&#xD;
      history, physical exam findings, imaging, and laboratory values, which are available to&#xD;
      physicians during the initial trauma resuscitation prior to a decision on whether to order an&#xD;
      abdominal computed tomography (CT) to evaluate for potential intra-abdominal injury; and 2)&#xD;
      Derive and validate a multi-variable clinical prediction rule based on data variables readily&#xD;
      available during the pediatric trauma resuscitation to identify patients at low risk for&#xD;
      intra-abdominal injury, in which unnecessary CT might safely be avoided. Information from&#xD;
      this study could be used to develop a more standardized approach to the evaluation for&#xD;
      intra-abdominal injury following blunt trauma in children. This information could lead to&#xD;
      significant improvement in the early recognition of injury and to improved resource&#xD;
      utilization.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The proposed research project is a prospective, observational study. Data will be collected&#xD;
      from each institution and entered into a secure REDCap database. Two phases of data&#xD;
      collection will occur: 1) patient demographics and specific clinical variables which may be&#xD;
      associated with IAI which are available and recorded during the initial trauma evaluation 2)&#xD;
      laboratory and imaging results available after the initial assessment, identified injuries,&#xD;
      patient disposition, interventions and outcomes.&#xD;
&#xD;
      Primary Outcome Variables: 1) Intra-abdominal injury (IAI) (presence of solid or hollow organ&#xD;
      injury (spleen, liver, kidney, GI tract, adrenal, pancreas, intra-abdominal vascular&#xD;
      structure, bladder, ureter, gallbladder, abdominal wall fascia)) 2) IAI requiring&#xD;
      intervention (abdominal operation, angio-embolization, blood transfusion)&#xD;
&#xD;
      Time Course: The initial data collection period will extend for one year. Data will be&#xD;
      recorded in a password protected redcap database which is readily available online to all&#xD;
      participating institutions.&#xD;
&#xD;
      Study setting: Eleven Level One Pediatric Trauma Centers&#xD;
&#xD;
      Data collection points: demographics (age, mechanism, alert level), physical exam, labs (AST,&#xD;
      HCT, amylase, UA, base deficit), FAST, imaging results, injuries, outcomes (admission, ICU&#xD;
      admit, need for intervention, missed injuries, ISS).&#xD;
&#xD;
      Data Analysis: De-identified data will be used during the data analysis phase to minimize the&#xD;
      risk of loss of confidentiality to the patients. Data analysis with development of a clinical&#xD;
      prediction rule (CPM) will be performed as follows. A logistic regression will be used to fit&#xD;
      a predictive model for both IAI and IAI requiring interventions. SAS 9.3 will be used for the&#xD;
      statistical analysis. Validation (including sensitivity and negative predictive value) of the&#xD;
      derived CPM would then be performed in a subsequent study using a second population of&#xD;
      patients. Internal validation of the prediction model was assessed by creating a split sample&#xD;
      using a random selection process; half of the sample was used as the initial cohort to&#xD;
      develop the prediction model for estimates of all covariates, and the remaining half was used&#xD;
      as the validation cohort to compare the true to the predicted outcomes. A receiver operating&#xD;
      characteristic (ROC) curve is created by plotting sensitivity against (1- specificity) for&#xD;
      different cut-off points of the predicted outcome. A bootstrap study of 1000 replications was&#xD;
      performed on the level of sensitivity, specificity and TP/FP/FN/TN validation. Validation&#xD;
      (including sensitivity and negative predictive value) of the derived CPM would then be&#xD;
      performed in a subsequent study using a second population of patients.&#xD;
&#xD;
      Quality assurance plan: Data quality will be evaluated bi-monthly by a team consisting of the&#xD;
      PI, an expert in clinical prediction models and a statistician. This panel will be able to&#xD;
      review de-identified data from all institutions but will not have access to make any changes&#xD;
      in the data entered in the centralized database.&#xD;
&#xD;
      Data checks to compare data entered into the registry against predefined rules for range or&#xD;
      consistency: Data checks to compare entered registry data against predefined rules for range&#xD;
      and consistency will be performed bi-monthly.&#xD;
&#xD;
      Source data verification: Source data collection is the responsibility of each individual&#xD;
      institution. A data analysis team consisting of a statistician and an expert in clinical&#xD;
      prediction models will evaluate the data bi-monthly to look for wide outliers (beyond&#xD;
      pre-defined range) and impossible data values (not clinically possible) and request&#xD;
      clarification from the individual institutions when necessary.&#xD;
&#xD;
      Data dictionary that contains detailed descriptions of each variable: The vast majority of&#xD;
      the data collection points are discrete variables with no opportunity for &quot;free text&quot; data&#xD;
      entry. Many of these variables are specifically described on the data collection tools. Data&#xD;
      definitions and question from the individual sites are addressed in a frequently updated&#xD;
      Frequently Asked Questions (FAQ) document which is sent out to the sites bi-monthly following&#xD;
      data verification review.&#xD;
&#xD;
      Standard Operating Procedures to address registry operations and analysis activities: The&#xD;
      database is established through a secure Vanderbilt Redcap web-based site. Individual site&#xD;
      data collection will be analyzed and reviewed bi-monthly with feedback to each of the sites&#xD;
      if data inconsistencies exist.&#xD;
&#xD;
      Plan for missing data to address situations where variables are reported as missing,&#xD;
      unavailable, &quot;non-reported,&quot; cannot be interpreted, or considered missing because of data&#xD;
      inconsistency or out-of-range results: Critical data which are missing, unavailable or not&#xD;
      reported will not be utilized for the development of the blunt abdominal trauma clinical&#xD;
      prediction model (BAT CPM). The investigators will attempt clarification for out of range&#xD;
      results prior to data analysis. Variables which are available and reported in less than 50%&#xD;
      of the patients will likely be excluded from the CPM because they will not form the basis of&#xD;
      a practicable risk stratification model. The developed CPM will require validation in a&#xD;
      second un-related population prior to widespread application of the CPM.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">January 2016</completion_date>
  <primary_completion_date type="Actual">October 2015</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>30 Days</target_duration>
  <primary_outcome>
    <measure>Intra-abdominal Injury (IAI)</measure>
    <time_frame>30 days from time of trauma</time_frame>
    <description>Intra-abdominal injury (IAI) (presence of solid or hollow organ injury (spleen, liver, kidney, GI tract, adrenal, pancreas, intra-abdominal vascular structure, bladder, ureter, gallbladder, abdominal wall fascia))</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Intraabdominal Injury (IAI) requiring intervention</measure>
    <time_frame>30 days from time of trauma</time_frame>
    <description>Intra-abdominal injury (IAI) requiring intervention (Laparoscopy or Laparotomy, angio-embolization, blood transfusion for IAI)</description>
  </primary_outcome>
  <enrollment type="Actual">2800</enrollment>
  <condition>Pediatric Abdominal Trauma</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Children with blunt abdominal trauma&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients presenting as a Trauma system activation with suspicion for blunt abdominal&#xD;
             trauma. (Fall &gt;10 feet; Motor vehicle accident &gt;40mph, pedestrian struck by auto,&#xD;
             Motor vehicle crash with ejection or death in vehicle or rollover, assault, bicycle&#xD;
             accident, ATV accident).&#xD;
&#xD;
          -  &lt;16 years of age&#xD;
&#xD;
          -  The need to activate the trauma system is dictated by the Emergency Department&#xD;
             physician&#xD;
&#xD;
          -  Consults called to the department of surgery for suspicion of intraabdominal traumatic&#xD;
             injury&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  16 years of age or older&#xD;
&#xD;
          -  Burn injury&#xD;
&#xD;
          -  Hanging&#xD;
&#xD;
          -  Drowning&#xD;
&#xD;
          -  Penetrating injury&#xD;
&#xD;
          -  CT A/P performed prior to arrival&#xD;
&#xD;
          -  Presentation &gt;6 hours from time of injury&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Isolated head injury&#xD;
&#xD;
          -  Fall &lt;10 feet with no concern for intraabdominal injury&#xD;
&#xD;
          -  Isolated extremity injury&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>15 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christian J Streck, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical University of South Carolina</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Children's Hospital of Alabama</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35233</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arkansas Children's Hospital</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LA Children's</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emory University</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boston Children's</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Mercy Hospital</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cincinnati Children's Hospital</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45255</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical University of South Carolina</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Le Bonheur Children's Hospital, The University of Tennessee Health Science Center</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Monroe Carell Jr. Children's Hospital at Vanderbilt</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Children's Hospital</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas Health Science Center at Houston</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of Richmond</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23220</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>July 31, 2014</study_first_submitted>
  <study_first_submitted_qc>July 31, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 1, 2014</study_first_posted>
  <last_update_submitted>May 2, 2018</last_update_submitted>
  <last_update_submitted_qc>May 2, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 3, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Intraabdominal Injury</keyword>
  <keyword>CT Abdomen and Pelvis</keyword>
  <keyword>Pediatric trauma</keyword>
  <keyword>blunt abdominal injury</keyword>
  <keyword>blunt trauma</keyword>
  <keyword>clinical prediction model</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wounds and Injuries</mesh_term>
    <mesh_term>Abdominal Injuries</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02206698
org study id: Pro00030071
nct id: NCT02206698
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
The submitted proposal is designed to reduce morbidity and mortality to injured children.
      Significant variability in the initial trauma assessment exists among institutions. The
      proposed project is a prospective, observational, multi-institutional study of children
      following blunt abdominal trauma. The specific goals of the project are to: 1) Document
      history, physical exam findings, imaging, and laboratory values, which are available to
      physicians during the initial trauma resuscitation prior to a decision on whether to order an
      abdominal computed tomography (CT) to evaluate for potential intra-abdominal injury; and 2)
      Derive and validate a multi-variable clinical prediction rule based on data variables readily
      available during the pediatric trauma resuscitation to identify patients at low risk for
      intra-abdominal injury, in which unnecessary CT might safely be avoided. Information from
      this study could be used to develop a more standardized approach to the evaluation for
      intra-abdominal injury following blunt trauma in children. This information could lead to
      significant improvement in the early recognition of injury and to improved resource
      utilization.
The proposed research project is a prospective, observational study. Data will be collected
      from each institution and entered into a secure REDCap database. Two phases of data
      collection will occur: 1) patient demographics and specific clinical variables which may be
      associated with IAI which are available and recorded during the initial trauma evaluation 2)
      laboratory and imaging results available after the initial assessment, identified injuries,
      patient disposition, interventions and outcomes.

      Primary Outcome Variables: 1) Intra-abdominal injury (IAI) (presence of solid or hollow organ
      injury (spleen, liver, kidney, GI tract, adrenal, pancreas, intra-abdominal vascular
      structure, bladder, ureter, gallbladder, abdominal wall fascia)) 2) IAI requiring
      intervention (abdominal operation, angio-embolization, blood transfusion)

      Time Course: The initial data collection period will extend for one year. Data will be
      recorded in a password protected redcap database which is readily available online to all
      participating institutions.

      Study setting: Eleven Level One Pediatric Trauma Centers

      Data collection points: demographics (age, mechanism, alert level), physical exam, labs (AST,
      HCT, amylase, UA, base deficit), FAST, imaging results, injuries, outcomes (admission, ICU
      admit, need for intervention, missed injuries, ISS).

      Data Analysis: De-identified data will be used during the data analysis phase to minimize the
      risk of loss of confidentiality to the patients. Data analysis with development of a clinical
      prediction rule (CPM) will be performed as follows. A logistic regression will be used to fit
      a predictive model for both IAI and IAI requiring interventions. SAS 9.3 will be used for the
      statistical analysis. Validation (including sensitivity and negative predictive value) of the
      derived CPM would then be performed in a subsequent study using a second population of
      patients. Internal validation of the prediction model was assessed by creating a split sample
      using a random selection process; half of the sample was used as the initial cohort to
      develop the prediction model for estimates of all covariates, and the remaining half was used
      as the validation cohort to compare the true to the predicted outcomes. A receiver operating
      characteristic (ROC) curve is created by plotting sensitivity against (1- specificity) for
      different cut-off points of the predicted outcome. A bootstrap study of 1000 replications was
      performed on the level of sensitivity, specificity and TP/FP/FN/TN validation. Validation
      (including sensitivity and negative predictive value) of the derived CPM would then be
      performed in a subsequent study using a second population of patients.

      Quality assurance plan: Data quality will be evaluated bi-monthly by a team consisting of the
      PI, an expert in clinical prediction models and a statistician. This panel will be able to
      review de-identified data from all institutions but will not have access to make any changes
      in the data entered in the centralized database.

      Data checks to compare data entered into the registry against predefined rules for range or
      consistency: Data checks to compare entered registry data against predefined rules for range
      and consistency will be performed bi-monthly.

      Source data verification: Source data collection is the responsibility of each individual
      institution. A data analysis team consisting of a statistician and an expert in clinical
      prediction models will evaluate the data bi-monthly to look for wide outliers (beyond
      pre-defined range) and impossible data values (not clinically possible) and request
      clarification from the individual institutions when necessary.

      Data dictionary that contains detailed descriptions of each variable: The vast majority of
      the data collection points are discrete variables with no opportunity for "free text" data
      entry. Many of these variables are specifically described on the data collection tools. Data
      definitions and question from the individual sites are addressed in a frequently updated
      Frequently Asked Questions (FAQ) document which is sent out to the sites bi-monthly following
      data verification review.

      Standard Operating Procedures to address registry operations and analysis activities: The
      database is established through a secure Vanderbilt Redcap web-based site. Individual site
      data collection will be analyzed and reviewed bi-monthly with feedback to each of the sites
      if data inconsistencies exist.

      Plan for missing data to address situations where variables are reported as missing,
      unavailable, "non-reported," cannot be interpreted, or considered missing because of data
      inconsistency or out-of-range results: Critical data which are missing, unavailable or not
      reported will not be utilized for the development of the blunt abdominal trauma clinical
      prediction model (BAT CPM). The investigators will attempt clarification for out of range
      results prior to data analysis. Variables which are available and reported in less than 50%
      of the patients will likely be excluded from the CPM because they will not form the basis of
      a practicable risk stratification model. The developed CPM will require validation in a
      second un-related population prior to widespread application of the CPM.
observational model: Cohort
time perspective: Prospective
measure: Intra-abdominal Injury (IAI)
time frame: 30 days from time of trauma
description: Intra-abdominal injury (IAI) (presence of solid or hollow organ injury (spleen, liver, kidney, GI tract, adrenal, pancreas, intra-abdominal vascular structure, bladder, ureter, gallbladder, abdominal wall fascia))
measure: Intraabdominal Injury (IAI) requiring intervention
time frame: 30 days from time of trauma
description: Intra-abdominal injury (IAI) requiring intervention (Laparoscopy or Laparotomy, angio-embolization, blood transfusion for IAI)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 15 Years
healthy volunteers: No
last name: Christian J Streck, MD
role: Principal Investigator
affiliation: Medical University of South Carolina
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Wounds and Injuries
mesh term: Abdominal Injuries