Diagnostic efficacy and effectiveness of primary whole-body computed tomography (Pan-CT) in severe and multiple trauma

ISRCTN	ISRCTN41462125
DOI	https://doi.org/10.1186/ISRCTN41462125
Protocol serial number	ukb/zkf_04/09
Sponsor	Unfallkrankenhaus Berlin Trauma Centre, Centre for Clinical Research (Germany)
Funder	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.

Submission date: 30/08/2009
Registration date: 18/09/2009
Last edited: 26/04/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Injury, Occupational Diseases, Poisoning

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Dirk Stengel
Scientific

Centre for Clinical Research
Department of Trauma and Orthopaedic Surgery
Unfallkrankenhaus Berlin
Berlin
12683
Germany

Phone	+49 3056813030
Email	dirk.stengel@ukb.de

Study information

Primary study design	Observational
Study design	PATRES-1: Retrospective diagnostic accuracy study PATRES-2: Prospective observational diagnostic effectiveness study
Secondary study design	Other
Study type	Participant information sheet
Scientific title	Primary whole-body computed tomography (Pan-CT) for Trauma Resuscitation Evaluation: a prospective diagnostic effectiveness trial with a retrospective diagnostic accuracy study
Study acronym	PATRES
Study objectives	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(s)	Approved by the Charité University Medical Centre in February 2009
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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])
Key secondary outcome measure(s)	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])
Completion date	31/12/2009

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	All
Target sample size at registration	700
Key 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
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	01/09/2009
Date of final enrolment	31/12/2009

Locations

Countries of recruitment

Germany

Study participating centre

Centre for Clinical Research

Berlin
12683
Germany

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	retrospective cohort study results	09/12/2011		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes