NCT01540318

Brief Summary

The major goal of this project is to conduct a randomized controlled trial studying an initial evaluation strategy with abdominal ultrasound versus a strategy without abdominal ultrasound for the evaluation of children with blunt abdominal trauma. The proposal's objectives are to compare the following variables in those that randomize to abdominal ultrasound versus those that do not:

  1. 1.rate of abdominal CT scanning
  2. 2.time to emergency department disposition
  3. 3.the rate of missed/delayed diagnosis of intra-abdominal injury
  4. 4.the costs.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
925

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2012

Completed
1 day until next milestone

Study Start

First participant enrolled

February 1, 2012

Completed
27 days until next milestone

First Posted

Study publicly available on registry

February 28, 2012

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

January 16, 2019

Status Verified

January 1, 2019

Enrollment Period

3.9 years

First QC Date

January 31, 2012

Last Update Submit

January 15, 2019

Conditions

Abdominal Injuries

Keywords

ultrasonographyAbdominal InjuriesTrauma

Outcome Measures

Primary Outcomes (1)

  • Rate of Abdominal CT Scan

    One week from enrollment

Secondary Outcomes (2)

  • Total time spent in the Emergency Department

    24 hours from enrollment

  • Cost effectiveness

    two months from enrollment

Study Arms (2)

Abdominal Ultrasound

EXPERIMENTAL

Patients in the experimental arm will receive a "Focused Assessment with Sonography for Trauma (FAST)" which includes the use of abdominal ultrasound.

Procedure: Abdominal Ultrasound (FAST examination)

No Abdominal Ultrasound

NO INTERVENTION

Interventions

Abdominal Ultrasound (FAST examination)PROCEDURE

Use of FAST abdominal ultrasound exam

Also known as: Focused Assesment with Sonography for Trauma
Abdominal Ultrasound

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Blunt torso trauma resulting from a significant mechanism of injury
  • Motor vehicle collision: greater than 60 mph, ejection, or rollover
  • Automobile versus pedestrian/bicycle: automobile speed \> 25 mph
  • Falls greater than 20 feet in height
  • Crush injury to the torso
  • Physical assault involving the abdomen
  • Decreased level of consciousness (Glasgow Coma Scale score \< 15 or below age-appropriate behavior) in association with blunt torso trauma
  • Blunt traumatic event with any of the following (regardless of the mechanism):
  • Extremity paralysis
  • Multiple long bone fractures (e.g., tibia and humerus fracture)
  • History and physical examination suggestive of intra-abdominal injury following blunt torso trauma of any mechanism (including mechanisms of injury of less severity than mentioned above)

You may not qualify if:

  • No concern for inter-abdominal injury or no planned evaluation for possible IAI
  • Prehospital or ED age adjusted Hypotension
  • Prehospital or initial ED GCS score ≤ 8
  • Presence of an abdominal "seat belt sign" - continuous area of erythema/contusion completely across the lower abdomen secondary to a lap belt
  • Penetrating trauma: stab or gunshot wounds
  • Traumatic injury occurring \> 24 hours prior to the time of presentation to the ED
  • Transfer of the patient to the UCDMC ED from an outside facility with abdominal CT scan, diagnostic peritoneal lavage, or laparotomy previously performed
  • Patients with known disease processes resulting in intraperitoneal fluid including liver failure and the presence of ventriculoperitoneal shunts

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UC Davis Medical Center

Sacramento, California, 95817, United States

Location

Related Publications (1)

  • Holmes JF, Kelley KM, Wootton-Gorges SL, Utter GH, Abramson LP, Rose JS, Tancredi DJ, Kuppermann N. Effect of Abdominal Ultrasound on Clinical Care, Outcomes, and Resource Use Among Children With Blunt Torso Trauma: A Randomized Clinical Trial. JAMA. 2017 Jun 13;317(22):2290-2296. doi: 10.1001/jama.2017.6322.

    PMID: 28609532DERIVED

MeSH Terms

Conditions

Abdominal InjuriesWounds and Injuries

Interventions

High-Energy Shock Waves

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Officials

  • James F Holmes, MD, MPH

    UC Davis School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2012

First Posted

February 28, 2012

Study Start

February 1, 2012

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

January 16, 2019

Record last verified: 2019-01

Locations

US(1)