- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00228111
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
Study Overview
Status
Conditions
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
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
-
Nijmegen, Netherlands, 6500 HB
- Radboud University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Collaborators and Investigators
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 and helpful links
General Publications
- Brink M, Deunk J, Dekker HM, Kool DR, Edwards MJ, van Vugt AB, Blickman JG. Added value of routine chest MDCT after blunt trauma: evaluation of additional findings and impact on patient management. AJR Am J Roentgenol. 2008 Jun;190(6):1591-8. doi: 10.2214/AJR.07.3277.
- Deunk J, Brink M, Dekker HM, Kool DR, van Kuijk C, Blickman JG, van Vugt AB, Edwards MJ. Routine versus selective computed tomography of the abdomen, pelvis, and lumbar spine in blunt trauma: a prospective evaluation. J Trauma. 2009 Apr;66(4):1108-17. doi: 10.1097/TA.0b013e31817e55c3.
- Brink M, Deunk J, Dekker HM, Edwards MJ, Kool DR, van Vugt AB, van Kuijk C, Blickman JG. Criteria for the selective use of chest computed tomography in blunt trauma patients. Eur Radiol. 2010 Apr;20(4):818-28. doi: 10.1007/s00330-009-1608-y. Epub 2009 Sep 17.
- Brink M, de Lange F, Oostveen LJ, Dekker HM, Kool DR, Deunk J, Edwards MJ, van Kuijk C, Kamman RL, Blickman JG. Arm raising at exposure-controlled multidetector trauma CT of thoracoabdominal region: higher image quality, lower radiation dose. Radiology. 2008 Nov;249(2):661-70. doi: 10.1148/radiol.2492080169.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2005/093
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Thoracic Injuries
-
University GhentCompletedThoracic InjuryBelgium
-
Assiut UniversityNot yet recruiting
-
Hospital de GranollersCompleted
-
Soroka University Medical CenterUnknownSurgery | Anesthesia | Thoracic Injury | Block
-
Second Affiliated Hospital, School of Medicine,...UnknownLung Ultrasound Score | Blunt Thoracic Injury
-
Antalya Training and Research HospitalCompleted
-
University of Cape TownMedical Research Council, South AfricaCompletedHeart InjuriesSouth Africa
-
Cook Research IncorporatedCompletedThoracic Injuries | Thoracic Aorta | Blunt InjuriesUnited States
-
University Hospital, LilleCompleted
-
University of ChileNot yet recruitingAnalgesia | Rib Fractures | Thoracic Tumors | Abdomen TumorsChile