Condition category
Injury, Occupational Diseases, Poisoning
Date applied
18/11/2013
Date assigned
16/12/2013
Last edited
07/11/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
We are conducting a study of 1000 patients with blunt penetrating major multiple trauma in order to compare two different methods of whole-body computed tomography (CT). This involves a native scan of the head and brain, and a contrast-enhanced scan of the neck and cervical spine, the chest, abdomen, and pelvis. Our objective is to find out whether CT using a lower than normal dose of radiation with an additional imaging software is as accurate and safe as the established CT scanning method. The findings may help to reduce unnecessary exposure to radiation for diagnostic purposes in severely injured patients while maintaining the proven diagnostic yield and therapeutic impact of the whole-body scan.

Who can participate?
Because of the specific condition, patients cannot be invited to participate in this study voluntarily. Most eligible patients will be unconscious and in a critical condition, demanding urgent diagnostics and often life-saving surgery.

What does the study involve?
A first group of 500 consecutive patients (men and women of all ages who, according to the trauma leader on call, are at risk of multiple trauma and need an immediate whole-body CT scan) will be imaged using the latest standard conventional dose protocol and a 128 multi-detector-row scanner.
The next group of 500 patients will undergo a dose-reduced protocol, using the iDoseTM (Philips, Eindhoven, The Netherlands) processing software.
All images will be re-read by independent experts, and compared to a synopsis of all findings collected during the study. We will determine the frequency of delayed diagnoses, the accuracy, and the radiation dose with either method. This study will mainly involve routine clinical and hospital data and we currently do not plan regular follow-up examinations.

What are the possible benefits and risks of participating?
This study mainly reflects routine care conditions. All patients will receive the current diagnostic standard care (whole-body CT in case of suspected major trauma). Patients in the normal-dose group may benefit from a higher resolution of images and better detection of injuries, but also have a very small life-time risk of radiation-induced cancer. For patients in the reduced-dose group, certain injuries could be missed, but they are only exposed to a radiation dose which is close to natural radiation levels.

Where is the study run from?
The DoReMI study is conducted at the Unfallkrankenhaus Berlin (ukb), a high-volume supra-regional trauma center in Berlin, Germany.

When is the study starting and how long is it expected to run for?
The study will be initiated in December 2013, and recruitment will start in January 2014. Given the current caseload and patient numbers, the enrolment period will last about two years.

Who is funding the study?
This is an investigator-initiated study, and funding is provided by the Unfallkrankenhaus Berlin (ukb) (Germany).

Who is the main contact?
Dirk Stengel, MD PhD MSc, dirk.stengel@ukb.de
Sven Mutze, MD PhD, sven.mutze@ukb.de

Trial website

Contact information

Type

Scientific

Primary contact

Dr Dirk Stengel

ORCID ID

Contact details

Center for Clinical Research
Dept. of Trauma and Orthopaedic Surgery
Unfallkrankenhaus
Berlin
12683
Germany
+493056814050
dirk.stengel@ukb.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

DoReMI CIP V2.1 17-09-2013

Study information

Scientific title

Dose Reduction in whole-body computed tomography (CT) scan evaluation of Multiple Injuries: A prospective cohort study with interrupted time-series analysis

Acronym

DoReMI

Study hypothesis

There is no difference between single-pass, whole-body 128-row multi-detector computed tomography (MDCT) at a low radiation dose using the iDose4 image processing algorithm (Philips, Eindhoven, The Netherlands) compared to conventional radiation dose MDCT with regard to:
1. The incidence of delayed diagnosis and delayed therapeutically relevant diagnosis until discharge
2. Diagnostic accuracy (in terms of sensitivity, specificity, positive and negative predictive value), as correlated to the reference standard of a synopsis of all subsequent clinical, imaging, surgical and autopsy findings
3. Patients’ safety
4. Radiation exposure (e.g. effective dose, volume CT dose index, dose-length-product)
5. General image quality (as independently assessed by two expert radiologists on a 100-mm visual analogue scale [VAS])
6. Objective image quality (e.g., contrast-to-noise ratio)
7. RNA / DNA instability / damage (to be used as a surrogate parameter)

Ethics approval

Charité University Medical Centre, EA2/048/13, October 30, 2013 (received November 11, 2013)

Study design

Single-center prospective observational study with two consecutive cohorts of patients and interrupted time-series analysis

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 below to request a patient information sheet

Condition

Clinical evidence of or high suspicion of multiple trauma

Intervention

Cohort 1: Normal-dose single-pass, whole-body MDCT

Cohort 2: Low-dose, single-pass, whole-body 128-row multi-detector computed tomography (MDCT) with iDose image processing algorithm.

Apart from the different scanning methods, this study will be observational in any other aspect of clinical care.
We will use routine data to compose the reference test to verify index test findings. We currently do not plan study-specific follow-up of participants.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Incidence of delayed diagnosis and delayed therapeutically relevant diagnosis until discharge.

Co-primary outcome: Diagnostic accuracy (in terms of sensitivity, specificity, positive and negative predictive value), as correlated to the reference standard of a synopsis of all subsequent clinical, imaging, surgical and autopsy findings.

Secondary outcome measures

1. Patients’ safety
2. Radiation exposure (e.g. effective dose, volume CT dose index, dose-length-product)
3. General image quality (as independently assessed by two expert radiologists on a 100-mm visual analogue scale [VAS])
4. Objective image quality (e.g., contrast-to-noise ratio)
5. RNA / DNA instability / damage (to be used as a surrogate parameter)

Overall trial start date

01/01/2014

Overall trial end date

01/01/2016

Reason abandoned

Eligibility

Participant inclusion criteria

We will collect data of all consecutive male and female patients of any age who:
1. Had been exposed to a high-velocity trauma mechanism (e.g., car crash, fall from height)
2. Present with clinical evidence or high suspicion of multiple trauma (predicted Injury Severity Score
[ISS] ≥16)
3. Re scheduled for primary, single-pass whole-body MDCT based on the decision of the trauma leader on call

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

500 eligible patients per cohort

Participant exclusion criteria

We will exclude patients who, at any time, withdraw consent of study participation.

Recruitment start date

01/01/2014

Recruitment end date

01/01/2016

Locations

Countries of recruitment

Germany

Trial participating centre

Center for Clinical Research
Berlin
12683
Germany

Sponsor information

Organisation

Emergency Hospital, Berlin (Unfallkrankenhaus Berlin) (Germany)

Sponsor details

Warener Str. 7
Berlin
12683
Germany
+493056814050
dirk.stengel@ukb.de

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

University/education

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

2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24589310

Publication citations

  1. Protocol

    Stengel D, Ottersbach C, Kahl T, Nikulka C, Güthoff C, Hartel T, Hünnebeck S, Ekkernkamp A, Mutze S, Dose reduction in whole-body computed tomography of multiple injuries (DoReMI): protocol for a prospective cohort study., Scand J Trauma Resusc Emerg Med, 2014, 22, 15, doi: 10.1186/1757-7241-22-15.

Additional files

Editorial Notes