Condition category
Injury, Occupational Diseases, Poisoning
Date applied
14/07/2011
Date assigned
24/08/2011
Last edited
17/08/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Lay summary under review 3

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) Munich, Germany approved on 16 March 2010

Study design

Retrospective cohort study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

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

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 measures

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

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

http://www.ukb.de/

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

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