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TRACT Study: Evaluation of the Value of Routine Thoraco-abdominal CT in Blunt Trauma Patients

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ClinicalTrials.gov Identifier: NCT00228111
Recruitment Status : Completed
First Posted : September 28, 2005
Last Update Posted : September 24, 2009
Sponsor:
Information provided by:
Radboud University

Brief Summary:
The aim of this study is to establish the additional effectiveness and costs of routine thoraco-abdominal computed tomography (CT) in blunt trauma patients versus conventional radiological imaging and to determine which clinical parameters predict a high additional value of routine thoraco-abdominal CT.

Condition or disease
Abdominal Injuries Thoracic Injuries

Detailed Description:

The technological advances in computed tomography (CT), with faster image acquisition resulting in higher resolution, result in making CT a more widely and intensively used imaging modality in trauma patient care. Thoraco-abdominal CT in addition appears to have additional diagnostic value compared to conventional radiography, especially in severely injured trauma patients.

Nowadays, both clinical data and conventional radiology are used to determine which patient should undergo body CT scanning. Currently there are no widely accepted guidelines for the use of a "standard" TRAuma CT (TRACT). Although many retrospective and several prospective cohort studies have been published on this topic, the data are not sufficient to sustain evidence-based practice in decision-making.

The aim of this study is, to establish the additional effectiveness and costs of routine thoraco-abdominal CT in blunt trauma patients versus conventional radiological imaging and to determine which clinical parameters predict a high additional value of routine thoraco-abdominal CT.

Consecutive trauma patients, who are at least 16 years old and are suffering from severe injuries, undergo a standard trauma CT of the cervical spine, the thorax and abdomen after clinical evaluation and conventional radiological workup.

Clinical, conventional and computed tomographic radiological assessment, costs, therapeutic consequences and 6 months patient follow up are recorded and will be statistically analyzed.


Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Evaluation of the Additional Value of Routine Thoraco-abdominal CT in Patients That Suffered Severe Blunt Trauma of the Abdomen/Thorax
Study Start Date : June 2005
Primary Completion Date : June 2008
Study Completion Date : December 2008

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult blunt trauma patients
Criteria

Inclusion Criteria:

  • Patients with life threatening vital problems: respiratory, circulatory (pulse > 120/min, blood pressure < 100 mmHg, refill > 4 sec, exterior blood loss > 500 ml) or neurologically (Glasgow Coma Score < 14, abnormal pupils) compromised patients.
  • Patients with a revised trauma score under 12
  • Patients with signs of fractures from at least two long bones
  • Patients with clinical signs of flail chest/multiple rib fractures
  • Patients with a clinically evident pelvic rim fracture
  • Patients with signs of unstable vertebral fractures or signs of neural cord compression
  • Patients involved in a high-energy injury mechanism

    • Fall from height (> 3 m)
    • As declared by prehospital emergency medical services

Exclusion Criteria:

  • Patients suffering from a shock Class IIIB/IV
  • Patients who need immediate neurosurgical intervention
  • Pregnant patients
  • Patients referred from other hospitals
  • Patients who die at the emergency department

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00228111


Locations
Netherlands
Radboud University
Nijmegen, Netherlands, 6500 HB
Sponsors and Collaborators
Radboud University
Investigators
Study Director: A.B. van Vugt, MD, PhD Radboud University, Dept. of Traumatology
Study Director: J.G. Blickman, MD, PhD Radboud University, Dept. of Radiology

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Radboud University Medical Centre
ClinicalTrials.gov Identifier: NCT00228111     History of Changes
Other Study ID Numbers: 2005/093
First Posted: September 28, 2005    Key Record Dates
Last Update Posted: September 24, 2009
Last Verified: September 2009

Keywords provided by Radboud University:
Computed tomography
wounds and injuries,non penetrating
algorithms
Blunt trauma of the thorax and abdomen

Additional relevant MeSH terms:
Wounds and Injuries
Thoracic Injuries
Wounds, Nonpenetrating
Abdominal Injuries