Plain English Summary
Background and study aims
Despite major improvements in emergency care, severe trauma, mainly due to road traffic crashes, falls, and assaults remains the leading cause of death in the industrialized countries. The rapid transfer of trauma victims to a specialized trauma centre is life-saving. On admission, the goal of diagnostic work-up is to identify life-threatening injuries, immediately followed by surgical and intensive care. The current diagnostic standard includes different imaging procedures like ultrasound, x-rays, and a cranial (head) computed tomography (CT) scan supplemented by CT scans of individual body regions as needed. In many trauma centres worldwide, this often time-consuming approach has now been replaced by a whole-body CT-scan, called the "pan-scan" for trauma. In theory, the pan-scan may detect injuries earlier and more precisely than the traditional stepwise procedure. Although compelling and plausible, there is a lack of evidence of whether the pan-scan benefits patients in terms of improved survival. The potential advantages of the pan-scan must also be traded-off against the increased exposure to radiation. The aim of this study is to find out whether the introduction of pan-scan into trauma resuscitation decreases mortality (death rate) for patients after severe blunt trauma compared to a conventional, staged work-up.
Who can participate?
Patients with suspected blunt multiple trauma requiring resuscitation in the emergency department/trauma bay
What does the study involve?
The outcomes of patients admitted before and after the introduction of pan-scan for severe trauma are compared. Mortality (death rate), adjusted for injury severity and other factors, morbidity (i.e. inflammatory complications like lung failure and multiple organ failure), and emergency department time are assessed.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
The University Trauma Centres in Murnau and Greifswald (Germany)
When is the study starting and how long is it expected to run for?
July to October 2011
Who is funding the study?
Investigator initiated and funded (Germany)
Who is the main contact?
Dr Dirk Stengel
zkf@ukb.de
Trial website
Contact information
Type
Scientific
Primary contact
Dr Dirk Stengel
ORCID ID
Contact details
Emergency Hospital Berlin (Unfallkrankenhaus Berlin)
Warener Str. 7
Berlin
12683
Germany
+49 (0)30 5681 4090
zkf@ukb.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
ukb_PATRES_3.2_0711
Study information
Scientific title
Effectiveness of primary whole-body computed tomography (pan-scan) in improving process and outcome quality after severe and multiple trauma (The Pan-scan for Trauma Resuscitation Study, Part 3)
Acronym
PATRES-3
Study hypothesis
The introduction of a single-pass whole-body, contrast-enhanced computed tomography (Pan-Scan) into trauma resuscitation decreases all-cause in hospital mortality of patients after severe blunt trauma compared to a conventional, staged work-up algorithm
Ethics approval
Bavarian Chamber of Physicians (Bayerische Landesärztekammer), 16/03/2010
Study design
Retrospective cohort study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Multiple and severe blunt trauma
Intervention
1. Control cohort: Trauma resuscitation and staged diagnostic work-up according to Advanced Trauma Life Support (ATLS(R)) standards including physical examination (ABCDE-algorithm), focused assessment with sonography for trauma (FAST, including thoracic views), plain x-rays of the chest, pelvis, and spine, cranial CT, followed by selective CT-scans of suspicious body regions
2. Intervention cohort: Trauma resuscitation and staged diagnostic work-up according to Advanced Trauma Life Support (ATLS(R)) standards, primary single-pass pan-scan
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
All-cause in-hospital mortality
Secondary outcome measures
1. All-cause in-hospital mortality, adjusted for injury severity and other confounding / interaction variables identified by multivariable logistic regression analysis
2. Morbidity (i.e. inflammatory complications like lung failure [ARDS] multiple organ failure [MOF])
3. Emergency department time
Overall trial start date
15/07/2011
Overall trial end date
01/10/2011
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Consecutive men and women (no age restrictions) with suspected blunt multiple trauma directly transferred from the scene to the hospital and requiring resuscitation in the emergency department / trauma bay
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
300 per group
Participant exclusion criteria
Due to the retrospective nature of this analysis only patients with insufficient or lacking information in the hospital documentation system will be excluded from the analysis
Recruitment start date
15/07/2011
Recruitment end date
01/10/2011
Locations
Countries of recruitment
Germany
Trial participating centre
Emergency Hospital Berlin (Unfallkrankenhaus Berlin)
Berlin
12683
Germany
Sponsor information
Organisation
Emergency Hospital Berlin (Unfallkrankenhaus Berlin) (Germany)
Sponsor details
Warener Str. 7
Berlin
12683
Germany
+49 (0)30 5681 4090
zkf@ukb.de
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Investigator initiated and funded (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/22152001
Publication citations
-
Results
Hutter M, Woltmann A, Hierholzer C, Gärtner C, Bühren V, Stengel D, Association between a single-pass whole-body computed tomography policy and survival after blunt major trauma: a retrospective cohort study., Scand J Trauma Resusc Emerg Med, 2011, 19, 73, doi: 10.1186/1757-7241-19-73.