Abdominal InjuriesNCT00228111
TRACT Study: Evaluation of the Value of Routine Thoraco-abdominal CT in Blunt Trauma Patients
An observational study of Abdominal Injuries and Thoracic Injuries, run by Radboud University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Abdominal Injuries, Thoracic Injuries
- How many people
- 1,000 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2005to Dec 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adult blunt trauma patients
Who may be able to join
- 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
Show all 9Show fewer
- Patients involved in a high-energy injury mechanism
- Fall from height (> 3 m)
- As declared by prehospital emergency medical services
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Abdominal Injuries, Thoracic Injuries
- Keywords
- Computed tomography, wounds and injuries,non penetrating, algorithms, Blunt trauma of the thorax and abdomen
- Medical subject headings
- Abdominal Injuries, Thoracic Injuries, Wounds and Injuries
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2005 (estimated)
- Study startJun 2005
- Primary completionJun 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Abdominal InjuriesStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- A.B. van Vugt, MD, PhD, Study director, Radboud University, Dept. of TraumatologyJ.G. Blickman, MD, PhD, Study director, Radboud University, Dept. of Radiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00228111
- Sponsor's protocol ID
- 2005/093
- Status last verified
- Sep 2009
- First submitted
- 22 Aug 2005
- Last updated
- 24 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 18492911Deunk 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.
PubMed 19359922Brink 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.
PubMed 19760233Brink 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.
PubMed 18936319
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of the Additional Value of Routine Thoraco-abdominal CT in Patients That Suffered Severe Blunt Trauma of the Abdomen/Thorax
- ClinicalTrials.gov ID
- NCT00228111
- Acronym / sponsor ID
- 2005/093
- Conditions
- Abdominal Injuries, Thoracic Injuries
- Keywords
- Computed tomography, wounds and injuries,non penetrating, algorithms, Blunt trauma of the thorax and abdomen
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Jun 2005
- Primary completion
- Jun 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 28 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult blunt trauma patients
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2009.
- Results publication: PubMed 18492911Brink 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.
- Results publication: PubMed 19359922Deunk 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.
- Results publication: PubMed 19760233Brink 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.
- Derived from this study: PubMed 18936319Brink 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
A.B. van Vugt, MD, PhD study director
Radboud University, Dept. of Traumatology
J.G. Blickman, MD, PhD study director
Radboud University, Dept. of Radiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Injuries and Thoracic Injuries, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00228111, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2009.