Pediatric Blunt Abdominal Trauma Clinical Prediction Model

NCT02206698 | Completed DMC

• 1 other identifier: Pro00030071
• Study Type: observational
• Target: 2,800
• Locations: 1 country
• Sites: 14

Brief Summary

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.

Conditions

Pediatric Abdominal Trauma

Keywords

Intraabdominal Injury; CT Abdomen and Pelvis; Pediatric trauma; blunt abdominal injury; blunt trauma; clinical prediction model

Outcome Measures

Primary Outcomes (2)

• Intra-abdominal Injury (IAI)

  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))

  30 days from time of trauma

• Intraabdominal Injury (IAI) requiring intervention

  Intra-abdominal injury (IAI) requiring intervention (Laparoscopy or Laparotomy, angio-embolization, blood transfusion for IAI)

  30 days from time of trauma

Eligibility Criteria

• Age: Up to 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children with blunt abdominal trauma

You may qualify if:

• Patients presenting as a Trauma system activation with suspicion for blunt abdominal trauma. (Fall \>10 feet; Motor vehicle accident \>40mph, pedestrian struck by auto, Motor vehicle crash with ejection or death in vehicle or rollover, assault, bicycle accident, ATV accident).
• \<16 years of age
• The need to activate the trauma system is dictated by the Emergency Department physician
• Consults called to the department of surgery for suspicion of intraabdominal traumatic injury

You may not qualify if:

• years of age or older
• Burn injury
• Hanging
• Drowning
• Penetrating injury
• CT A/P performed prior to arrival
• Presentation \>6 hours from time of injury
• Pregnancy
• Isolated head injury
• Fall \<10 feet with no concern for intraabdominal injury
• Isolated extremity injury

Sponsors & Collaborators

• Medical University of South Carolina: lead
• Monroe Carell Jr. Children's Hospital at Vanderbilt: collaborator
• University of Arkansas: collaborator
• University of Alabama at Birmingham: collaborator
• Virginia Commonwealth University: collaborator
• Children's Mercy Hospital Kansas City: collaborator
• University of Tennessee: collaborator
• Memorial Hermann Hospital: collaborator
• Baylor College of Medicine: collaborator
• Children's Hospital Los Angeles: collaborator
• Children's Hospital Medical Center, Cincinnati: collaborator
• Washington University School of Medicine: collaborator
• Boston Children's Hospital: collaborator
• Emory University: collaborator

Study Sites (14)

Children's Hospital of Alabama

Birmingham, Alabama, 35233, United States

Location

Arkansas Children's Hospital

Little Rock, Arkansas, 72202, United States

Location

LA Children's

Los Angeles, California, United States

Location

Emory University

Atlanta, Georgia, United States

Location

Boston Children's

Boston, Massachusetts, United States

Location

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

Washington University

St Louis, Missouri, United States

Location

Cincinnati Children's Hospital

Cincinnati, Ohio, 45255, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Le Bonheur Children's Hospital, The University of Tennessee Health Science Center

Memphis, Tennessee, 38105, United States

Location

Monroe Carell Jr. Children's Hospital at Vanderbilt

Nashville, Tennessee, 37232, United States

Location

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Children's Hospital of Richmond

Richmond, Virginia, 23220, United States

Location

Related Publications (1)

• Frederick AB, Vogel AM, Williams RF, Zhang J, Huang EY, Savoie KB, Santore MT, Tsao K, Falcone RA, Dassinger MS, Haynes JH, Russell RT, Naik-Mathuria BJ, St Peter SD, Mooney DP, Onwubiko C, Blakely ML, Streck CJ. Multicenter external validation of the Pediatric Emergency Care Applied Research Network rule to identify children at very low risk for intra-abdominal injury requiring acute intervention. J Trauma Acute Care Surg. 2025 Jun 1;98(6):966-972. doi: 10.1097/TA.0000000000004597. Epub 2025 Apr 2.

  PMID: 40170217 DERIVED

MeSH Terms

Conditions

Wounds, Nonpenetrating

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Christian J Streck, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2014
• First Posted: August 1, 2014
• Study Start: July 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: January 1, 2016
• Last Updated: May 3, 2018

Record last verified: 2018-05

Locations

US (14)