Contact information
Type
Scientific
Primary contact
Dr Dirk Stengel
ORCID ID
Contact details
Centre for Clinical Research
Department of Trauma and Orthopaedic Surgery
Unfallkrankenhaus Berlin
Berlin
12683
Germany
+49 3056813030
dirk.stengel@ukb.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
ukb/zkf_04/09
Study information
Scientific title
Primary whole-body computed tomography (Pan-CT) for Trauma Resuscitation Evaluation: a prospective diagnostic effectiveness trial with a retrospective diagnostic accuracy study
Acronym
PATRES
Study hypothesis
Hypotheses (formulated as clinical rather than null-hypotheses):
1. Primary whole-body computed tomography (Pan-CT) is highly sensitive to exclude and highly specific to recognise life-threatening injuries in multiple trauma
2. Pan-CT significantly affects the clinical pre-test probability of certain injuries and influences clinical decision making
Ethics approval
Approved by the Charité University Medical Centre in February 2009
Study design
PATRES-1: Retrospective diagnostic accuracy study
PATRES-2: Prospective observational diagnostic effectiveness study
Primary study design
Observational
Secondary study design
Other
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Blunt and penetrating multiple trauma
Intervention
PATRES-1: Hospital charts and RIS/PACS data of the patients will be studied retrospectively to determine diagnostic accuracy of Pan-CT.
PATRES-2: Prospective observational study of patients undergoing Pan-CT. The diagnostic results will be assessed by comparing the initial clinical judgement, pre-test probability, and therapeutic plan of the trauma leader (an experienced trauma and orthopaedic surgeon who considers injury mechanism, clinical and ultrasound findings) immediately before Pan-CT, and after Pan-CT results.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
PATRES-1: Accuracy of Pan-CT (i.e. sensitivity, specificity, area under the ROC curve) for diagnosing i) multiple trauma, ii) individual injuries. A synopsis of all diagnoses obtained during the hospital stay (e.g. CT-scans, clinical, intra-operative, and autopsy findings) will serve as the reference standard. All images will be re-read by experienced trauma radiologists, and hospital charts will independently be evaluated by trauma surgeons.
PATRES-2:
1. Shift in the pre-test probability of the prevalence and severity of injuries as judged by trauma surgeons prior to and after Pan-CT
2. Related changes in clinical decision making (e.g., emergency surgery, transfer to intensive care unit [ICU])
Secondary outcome measures
PATRES-1:
1. Rate of unnecessary CT-scans
2. Discrepancy between first and second readings
PATRES-2: Perceived value and effectiveness of CT-scans by trauma leaders (immediately after availability of CT-scans [i.e. at the trauma bay])
Overall trial start date
01/09/2009
Overall trial end date
31/12/2009
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
PATRES-1: Hospital charts and Radiology Information System/Picture Archiving and Communication System (RIS/PACS) data from consecutive male and female patients (no age limits) who i) had been admitted to the emergency department of a metropolitan trauma centre between 01/2008 and 06/2009 and ii) were referred to Pan-CT because of suspected multiple trauma by the physician on charge
PATRES-2: Trauma leaders caring for consecutive male and female patients (no age limits) who are admitted to the emergency department of a metropolitan trauma centre and are referred to Pan-CT because of suspected multiple trauma
Participant type
Patient
Age group
Other
Gender
Both
Target number of participants
PATRES-1: n=600, PATRES-2: n=100
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
01/09/2009
Recruitment end date
31/12/2009
Locations
Countries of recruitment
Germany
Trial participating centre
Centre for Clinical Research
Berlin
12683
Germany
Sponsor information
Organisation
Unfallkrankenhaus Berlin Trauma Centre, Centre for Clinical Research (Germany)
Sponsor details
Warener Str. 7
Berlin
12683
Germany
+49 3056813030
dirk.stengel@ukb.de
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Other
Funder name
Investigator-initiated trial without commercial funding. Study logistics and personnel will be provided by the Centre for Clinical Research of the Unfallkrankenhaus Berlin (Germany), and related costs will be covered by the investigator.
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
1. 2011 retrospective cohort study results in http://www.ncbi.nlm.nih.gov/pubmed/22152001
Publication citations
-
Retrospective cohort study 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.