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

This study has been completed.
Sponsor:
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00228111
First received: August 22, 2005
Last updated: September 23, 2009
Last verified: September 2009
  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

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Radboud University:

Estimated Enrollment: 1000
Study Start Date: June 2005
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Additional 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
Study First Received: August 22, 2005
Last Updated: September 23, 2009
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

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

ClinicalTrials.gov processed this record on July 29, 2014