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

This study is ongoing, but not recruiting participants.

Sponsored by: Radboud University
Information provided by: Radboud University
ClinicalTrials.gov Identifier: NCT00228111
  Purpose

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
Abdominal Injuries
Thoracic Injuries

MedlinePlus related topics:   Injuries    Wounds   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Cohort, 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

Further study details as provided by Radboud University:

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment:   1000
Study Start Date:   June 2005
Estimated Study Completion Date:   December 2008
Primary Completion Date:   June 2008 (Final data collection date for primary outcome measure)

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.

  Eligibility
Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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    
  More Information


Publications of Results:

Responsible Party:   Radboud University Medical Centre
Study ID Numbers:   2005/093
First Received:   August 22, 2005
Last Updated:   July 1, 2008
ClinicalTrials.gov Identifier:   NCT00228111
Health Authority:   Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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

Study placed in the following topic categories:
Thoracic Injuries
Wounds and Injuries
Disorders of Environmental Origin
Wounds, Nonpenetrating
Abdominal Injuries

ClinicalTrials.gov processed this record on October 06, 2008




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