Score Predicting Lesion Development on CT Following Mild TBI

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

20000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-01

Study Completion Date

2025-12-31

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.

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Detailed Description

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Conditions

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Traumatic Brain Injury Mild Traumatic Brain Injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Included patients

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Head CT to determine presence of traumatic intracranial lesion

Intervention Type RADIATION

Head CT to determine presence of traumatic intracranial lesion

Interventions

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Head CT to determine presence of traumatic intracranial lesion

Intervention Type RADIATION

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

Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No