Condition category
Injury, Occupational Diseases, Poisoning
Date applied
30/08/2009
Date assigned
18/09/2009
Last edited
26/04/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.ukb.de/de/main/home_2.htm

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

Results - basic reporting

Publication summary

1. 2011 retrospective cohort study results in http://www.ncbi.nlm.nih.gov/pubmed/22152001

Publication citations

  1. 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.

Additional files

Editorial Notes