Actively Recruiting

Age: 15Years +
All Genders
NCT04995068

Score Predicting Lesion Development on CT Following Mild TBI

Led by Karolinska Institutet · Updated on 2025-03-10

20000

Participants Needed

1

Research Sites

252 weeks

Total Duration

On this page

Sponsors

K

Karolinska Institutet

Lead Sponsor

K

Karolinska University Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Score Predicting Lesion Development on CT Following Mild TBI

Who Can Participate

Age: 15Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult (≥ 15 years)
  • Presented to emergency department within 24 hours of traumatic brain injury
  • Glasgow Coma Scale 13-15 at presentation to the emergency department
Not Eligible

You will not qualify if you...

  • No CT scan performed
  • Patient from another region in Sweden or another country
  • Penetrating traumatic brain injury
  • Secondary transfer from another emergency department
  • Missing medical record

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Karolinska University Hospital

Stockholm, Sweden

Actively Recruiting

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Research Team

E

Eric P Thelin, MD, PhD

CONTACT

A

Alexander Fletcher-Sandersjöö, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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