Computed Tomography Clinical Trial
Official title:
Use of Cerebral Computed Tomography on Patients With Minor Head Injuries in a Danish Emergency Department: A Retrospective Cohort Study
NCT number | NCT06399913 |
Other study ID # | UNIFY |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 1, 2023 |
Est. completion date | January 30, 2024 |
Verified date | April 2024 |
Source | University of Southern Denmark |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 7106 |
Est. completion date | January 30, 2024 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Odense University Hospital | Odense | Region Syddanmark |
Lead Sponsor | Collaborator |
---|---|
University of Southern Denmark |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 30-day mortality and readmission rate | We aim to evaluate the 30-day mortality and readmission rates to a hospital following CTC performed in the ED. | 1 year | |
Other | Neurological intervention | 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 | |
Primary | 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 |
1 year | |
Secondary | 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 | 1 year |
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