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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date April 2024
Source University of Southern Denmark
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. Secondary, we aim to evaluate the Scandinavian Neurotrauma Committee clinical guideline 2013 for minor head injury.


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.


Recruitment information / eligibility

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

Study Design


Locations

Country Name City State
Denmark Odense University Hospital Odense Region Syddanmark

Sponsors (1)

Lead Sponsor Collaborator
University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

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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