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TRACT Study: Evaluation of the Value of Routine Thoraco-abdominal CT in Blunt Trauma Patients
This study has been completed.
Study NCT00228111   Information provided by Radboud University
First Received: August 22, 2005   Last Updated: September 23, 2009   History of Changes

August 22, 2005
September 23, 2009
June 2005
June 2008   (final data collection date for primary outcome measure)
 
 
Complete list of historical versions of study NCT00228111 on ClinicalTrials.gov Archive Site
 
 
 
TRACT Study: Evaluation of the Value of Routine Thoraco-abdominal CT in Blunt Trauma Patients
Prospective Evaluation of the Additional Value of Routine Thoraco-abdominal CT in Patients That Suffered Severe Blunt Trauma of the Abdomen/Thorax

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.

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.

 
Observational
Cohort, Prospective
  • Abdominal Injuries
  • Thoracic Injuries
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
1000
December 2008
June 2008   (final data collection date for primary outcome measure)

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
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00228111
Radboud University Medical Centre
2005/093
Radboud University
 
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
Radboud University
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP