Computed TomographyNCT06399913
Cerebral Computed Tomography on Patients With Minor Head Injuries
An observational study of Computed Tomography and Minor Head Injuries, run by University of Southern Denmark at 1 site in Denmark.
Trial summary
This observational study aims to calculate the prevalence of conditions or diseases requiring immediate medical attention in CTC scans with an indication of bleeding post trauma performed in the ED at Odense University Hospital. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Computed Tomography, Minor Head Injuries
- How many people
- 7,106 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 2023to 30 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: CTCs conducted from 01.01.2023 to 31.12.2023 at Odense University Hospital (OUH) Emergency Department (ED) in Denmark.
Who may be able to join
- CTCs conducted from 01.01.2023 to 31.12.2023 in the ED
Who cannot join
- unrelated to trauma
- scans performed on patients under the age of 18
- CTC scans without radiologic interpretation
- Previously undergone a CTC during the same hospitalization, only the first CTC was included
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Cerebral Computed Tomography on Patients With Minor Head Injuries in a Danish Emergency Department: A Retrospective Cohort Study
This observational study aims to calculate the prevalence of conditions or diseases requiring immediate medical attention in CTC scans with an indication of bleeding post trauma performed in the ED at Odense University Hospital. Secondary, we aim to evaluate the Scandinavian Neurotrauma Committee clinical guideline 2013 for minor head injury.
Read the detailed description
In this retrospective study, our primary objectives are threefold: first, to calculate the prevalence of conditions or diseases requiring immediate medical attention and to subdivide them to explore potential correlations with biochemical, clinical, and patient baseline variables using multiple regression analysis. Secondly, we wanted to analyze our use of SNC CPG and evaluate if a more stringent application could reduce the potentially unnecessary overuse of CTC. Lastly, we aim to evaluate the 30-day mortality and readmission rates to a hospital following CTC performed in the ED.
- Conditions
- Computed Tomography, Minor Head Injuries
- Keywords
- Emergency Department, S100B, Scandinavian Neurotrauma Committee Guideline, Traumatic Brain Injuries
- Medical subject headings
- Craniocerebral Trauma, Emergencies, Brain Injuries, Traumatic
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive CTC
Calculate the prevalence of positive CTC findings and to subdivide them to explore potential correlations with biochemical, clinical, and patient baseline variables.
The CT scan was acknowledged as positive if the final radiologic interpretation of all imaging studies reported one or more listed radiological findings:
- Epidural hematoma
- Subdural hematoma
- Subarachnoid hematoma
- Intraparenchymal hematoma (IPH)
- Intraventricular hematoma
- Fossa posterior hematoma
- Acute infarct or dense artery sign
- Mass effect or sulcal effacement
- Signs of herniation
- Basal cistern compression or midline shift
- Cerebral contusion
- Depressed skull fracture
- Diastatic skull fracture
- Pneumocephalus
- Cerebral edema
- Diffuse axonal injury
- Tumor
- Intracranial infection
- Other which resulted in hospitalization
Measured: 1 year
Secondary outcomes (1)
Scandinavian Neurotrauma Committee clinical practice guideline evaluation
We wanted to analyze our use of SNC CPG and evaluate if a more stringent application could reduce the potentially unnecessary overuse of CTC
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2024
- Study start1 Jan 2023
- Primary completion31 Dec 2023
- Study completion30 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Computed TomographyStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 7,106 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonas Junghans Jensen, Principal investigator, UNIFY, University Hospital Odense, Univeristy of Southern Denmark, OPEN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06399913
- Sponsor's protocol ID
- UNIFY
- Status last verified
- Apr 2024
- First submitted
- 30 Apr 2024
- Last updated
- 6 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Cerebral Computed Tomography on Patients With Minor Head Injuries in a Danish Emergency Department: A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT06399913
- Acronym / sponsor ID
- UNIFY
- Conditions
- Computed Tomography, Minor Head Injuries
- Keywords
- Emergency Department, S100B, Scandinavian Neurotrauma Committee Guideline, Traumatic Brain Injuries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,106 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 6 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This observational study aims to calculate the prevalence of conditions or diseases requiring immediate medical attention in CTC scans with an indication of bleeding post trauma performed in the ED at Odense University Hospital. Secondary, we aim to evaluate the Scandinavian Neurotrauma Committee clinical guideline 2013 for minor head injury.
Detailed description
In this retrospective study, our primary objectives are threefold: first, to calculate the prevalence of conditions or diseases requiring immediate medical attention and to subdivide them to explore potential correlations with biochemical, clinical, and patient baseline variables using multiple regression analysis. Secondly, we wanted to analyze our use of SNC CPG and evaluate if a more stringent application could reduce the potentially unnecessary overuse of CTC. Lastly, we aim to evaluate the 30-day mortality and readmission rates to a hospital following CTC performed in the ED.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- CTCs conducted from 01.01.2023 to 31.12.2023 at Odense University Hospital (OUH) Emergency Department (ED) in Denmark.
Key inclusion criteria (1 listed)
- CTCs conducted from 01.01.2023 to 31.12.2023 in the ED
Key exclusion criteria (4 listed)
- unrelated to trauma
- scans performed on patients under the age of 18
- CTC scans without radiologic interpretation
- Previously undergone a CTC during the same hospitalization, only the first CTC was included
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Positive CTC
Time frame: 1 year
Calculate the prevalence of positive CTC findings and to subdivide them to explore potential correlations with biochemical, clinical, and patient baseline variables. The CT scan was acknowledged as positive if the final radiologic interpretation of all imaging studies reported one or more listed radiological findings: * Epidural hematoma * Subdural hematoma * Subarachnoid hematoma * Intraparenchymal hematoma (IPH) * Intraventricular hematoma * Fossa posterior hematoma * Acute infarct or dense artery sign * Mass effect or sulcal effacement * Signs of herniation * Basal cistern compression or midline shift * Cerebral contusion * Depressed skull fracture * Diastatic skull fracture * Pneumocephalus * Cerebral edema * Diffuse axonal injury * Tumor * Intracranial infection * Other which resulted in hospitalization
1 secondary outcome
Scandinavian Neurotrauma Committee clinical practice guideline evaluation
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonas Junghans Jensen principal investigator
UNIFY, University Hospital Odense, Univeristy of Southern Denmark, OPEN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Computed Tomography and Minor Head Injuries, run by University of Southern Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive CTC (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2024.