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Lowering the radiation dose in whole-body computed tomography of seriously injured patients using new imaging-processing software

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN74557102
Enrollment
1000
Registered
2013-12-16
Start date
2014-01-01
Completion date
Unknown
Last updated
2020-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clinical evidence of or high suspicion of multiple trauma Injury, Occupational Diseases, Poisoning Trauma

Interventions

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.

Sponsors

Emergency Hospital, Berlin (Unfallkrankenhaus Berlin) (Germany)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
1. Patient? 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)

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 21, 2026