Score Predicting Lesion Development on CT Following Mild TBI

Recruiting

• Conditions: Mild Traumatic Brain Injury; Traumatic Brain Injury
• Interventions: Radiation: Head CT to determine presence of traumatic intracranial lesion

• Registration Number: NCT04995068
• Lead Sponsor: Karolinska Institutet

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-01
• Study First Submitted: 2021-07-27
• Study First Submitted QC: 2021-08-04
• Study First Posted: 2021-08-06
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-13
• Last Update Posted: 2023-03-15
• Primary Completion: 2023-12-31
• Study Completion: 2024-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20000

Inclusion Criteria

• Adult (≥ 15 years)
• Presented to emergency department within 24 hours of TBI
• GCS 13-15 at presentation to the emergency department

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Included patients	Head CT to determine presence of traumatic intracranial lesion	See inclusion and exclusion criteria

Primary Outcome Measures

Name	Time	Method
Traumatic intracranial lesion	Immediately after the procedure (CT-scan)	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.

Secondary Outcome Measures

Name	Time	Method
Clinically significant traumatic intracranial lesion	Immediately after the procedure (CT-scan)	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
Lesion progression	Within 48 hours of the first CT-scan	Hemorrhagic primary outcome measure (cerebral contusion, subdural haematoma, epidural haematoma, subarachnoid haemorrhage or intraventricular haemorrhage) that progressed on a follow-up CT

Trial Locations

Locations (1)

Karolinska University Hospital; 🇸🇪 Stockholm, Sweden