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

Completed

• Conditions: Abdominal Injuries; Thoracic Injuries

• Registration Number: NCT00228111
• Lead Sponsor: Radboud University Medical Center

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.

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 Timeline

• Study Start: 2005-06
• Study First Submitted: 2005-08-22
• Study First Submitted QC: 2005-09-27
• Study First Posted: 2005-09-28
• Primary Completion: 2008-06
• Study Completion: 2008-12
• Status Verified: 2009-09
• Last Update Submitted: 2009-09-23
• Last Update Posted: 2009-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Radboud University; 🇳🇱 Nijmegen, Netherlands