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Clinical Trials/NCT04995068
NCT04995068
Recruiting
Not Applicable

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

Karolinska Institutet1 site in 1 country20,000 target enrollmentMarch 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Traumatic Brain Injury
Sponsor
Karolinska Institutet
Enrollment
20000
Locations
1
Primary Endpoint
Traumatic intracranial lesion
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2021
End Date
December 31, 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Eric Thelin

Principle Investigator

Karolinska Institutet

Eligibility Criteria

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

Outcomes

Primary Outcomes

Traumatic intracranial lesion

Time Frame: 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 Outcomes

  • Clinically significant traumatic intracranial lesion(Immediately after the procedure (CT-scan))
  • Lesion progression(Within 48 hours of the first CT-scan)

Study Sites (1)

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