Score Predicting Lesion Development on CT Following Mild TBI (SELECT-TBI)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Traumatic Brain Injury; Mild Traumatic Brain Injury
• Intervention / Treatment: Radiation: Head CT to determine presence of traumatic intracranial lesion

• Study Type: Observational
• Enrollment (Estimated): 20000

Contacts and Locations

• Study Contact: Name: Eric P Thelin, MD, PhD; Phone Number: 0046739365450; Email: eric.thelin@ki.se
• Study Contact Backup: Name: Alexander Fletcher-Sandersjöö, MD; Email: alexander.fletcher-sandersjoo@ki.se

Study Locations

• Sweden
  • Stockholm, Sweden
    • Recruiting
    • Karolinska University Hospital
    • Contact: Eric P Thelin, MD; Phone Number: 0046739365450; Email: eric.thelin@ki.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adults (≥ 15 years) with mild traumatic brain injury (GCS 13-15) who presented to the emergency department within 24 hours of injury.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Included patients; See inclusion and exclusion criteria	Radiation: Head CT to determine presence of traumatic intracranial lesion; Head CT to determine presence of traumatic intracranial lesion

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Karolinska University Hospital; Danderyd Hospital; Sodertalje Hospital; Norrtalje Hospital; St Goran's Hospital
• Investigators: Principal Investigator: Eric P Thelin, MD, PhD, Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: July 27, 2021
• First Submitted That Met QC Criteria: August 4, 2021
• First Posted (Actual): August 6, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 6, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: neurosurgery
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds, Nonpenetrating; Brain Injuries, Traumatic; Wounds and Injuries; Brain Injuries; Brain Concussion
• Other Study ID Numbers: 2020-05728

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The datasets used and/or analyzed during the planned study will be available from the corresponding author on reasonable request.
• IPD Sharing Time Frame: Following publication of the study, the above will be available from the corresponding author on reasonable request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No