Score Predicting Lesion Development on CT Following Mild TBI

Study Overview
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Brief Summary
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Mild traumatic brain injury (mTBI) is one of the most common reasons behind emergency department (ED) visits. A small portion of mTBI patients will develop an intracranial lesion that might require neurosurgical intervention. Several guidelines have been developed to help direct these patients for head Computerized Tomography (CT) scanning, but they lack specificity, mainly focus on ruling out lesions, and do not estimate the risk of lesion development. The aim of this retrospective observational study is to create a risk stratification score that predicts the likelihood of intracranial lesion development, lesion progression, and need for neurosurgical management in patients with mTBI presenting to the ED. Eligible patients are adults (≥ 15 years) with mTBI (defined as admission Glasgow Coma Scale (GCS) 13-15) who presented to the ED within 24 hours of injury to any ED in Stockholm, Sweden between 2010-2020. Reasons for ED visit and Internal Classification of Disease (ICD) codes will be used to screen for patients. Machine-learning models will be applied. The primary outcome will be a traumatic lesion on head CT, defined as a cerebral contusion, subdural haematoma, epidural haematoma, subarachnoid haemorrhage, intraventricular haemorrhage, diffuse axonal injury, skull fracture, traumatic infarction or sinus thrombosis. The secondary outcomes will be any clinically significant lesion, defined as an intracranial finding that led to neurosurgical intervention, discontinuation or reversal of anticoagulant or antiplatelet medication, hospital admission > 48 hours due to the TBI, or death.

Official Title
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Stockholm Score of Lesion Development on Computerized Tomography Following Mild Traumatic Brain Injury

Conditions
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Traumatic Brain Injury, Mild Traumatic Brain Injury

Intervention / Treatment
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* Radiation: Head CT to determine presence of traumatic intracranial lesion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult (≥ 15 years) Presented to emergency department within 24 hours of TBI GCS 13-15 at presentation to the emergency department Exclusion Criteria: No CT scan performed Patient from another Region in Sweden/another country Penetrating TBI Secondary transfer from other emergency department Medical record missing

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Included patients<br>See inclusion and exclusion criteria | Radiation: Head CT to determine presence of traumatic intracranial lesion<br>* Head CT to determine presence of traumatic intracranial lesion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Traumatic intracranial lesion | Any traumatic lesion on head CT, defined as a cerebral contusion, subdural haematoma, epidural haematoma, subarachnoid haemorrhage, intraventricular haemorrhage, diffuse axonal injury, skull fracture, traumatic infarction or sinus thrombosis. | Immediately after the procedure (CT-scan) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinically significant traumatic intracranial lesion | Primary outcome measure that led to neurosurgical intervention, discontinuation or reversal of anticoagulant or antiplatelet medication, hospital admission > 48 hours due to the TBI, or death due to TBI | Immediately after the procedure (CT-scan) | 
| Lesion progression | Hemorrhagic primary outcome measure (cerebral contusion, subdural haematoma, epidural haematoma, subarachnoid haemorrhage or intraventricular haemorrhage) that progressed on a follow-up CT | Within 48 hours of the first CT-scan | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neurosurgery