- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06399913
Cerebral Computed Tomography on Patients With Minor Head Injuries
April 30, 2024 updated by: University of Southern Denmark
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
7106
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Region Syddanmark
-
Odense, Region Syddanmark, Denmark, 5000
- Odense University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
CTCs conducted from 01.01.2023 to 31.12.2023 at Odense University Hospital (OUH) Emergency Department (ED) in Denmark.
Description
Inclusion Criteria:
- CTCs conducted from 01.01.2023 to 31.12.2023 in the ED
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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:
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Scandinavian Neurotrauma Committee clinical practice guideline evaluation
Time Frame: 1 year
|
We wanted to analyze our use of SNC CPG and evaluate if a more stringent application could reduce the potentially unnecessary overuse of CTC
|
1 year
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
30-day mortality and readmission rate
Time Frame: 1 year
|
We aim to evaluate the 30-day mortality and readmission rates to a hospital following CTC performed in the ED.
|
1 year
|
|
Neurological intervention
Time Frame: 1 year
|
The need for neurological intervention was defined as within 7 days requiring 1) neurosurgical intervention (e.g., craniotomy, hematoma evacuation, elevation of skull fracture, intracranial pressure monitoring, or intubation for head injuries indicated on CT) or 2) neuroradiological intervention (e.g., thrombectomy or intravascular embolization).
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jonas Junghans Jensen, UNIFY, University Hospital Odense, Univeristy of Southern Denmark, OPEN
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2023
Primary Completion (Actual)
December 31, 2023
Study Completion (Actual)
January 30, 2024
Study Registration Dates
First Submitted
April 30, 2024
First Submitted That Met QC Criteria
April 30, 2024
First Posted (Actual)
May 6, 2024
Study Record Updates
Last Update Posted (Actual)
May 6, 2024
Last Update Submitted That Met QC Criteria
April 30, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UNIFY
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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