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NCT Number: NCT04995068

Score Predicting Lesion Development on CT Following Mild TBI

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.

Recruiting

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Key information

Age range

15 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Head CT to determine presence of traumatic intracranial lesion

Radiation

Head CT to determine presence of traumatic intracranial lesion

Primary outcomes

  1. 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

  1. Clinically significant traumatic intracranial lesion

    Time frame: 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

  2. Lesion progression

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Alexander Fletcher-Sandersjöö, MD

CONTACT

[email protected]

Eric P Thelin, MD, PhD

CONTACT

[email protected]

0046739365450

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Danderyd Hospital
  • Karolinska University Hospital
  • Norrtalje Hospital
  • Sodertalje Hospital
  • St Goran's Hospital

Registry information

Official study title

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

Acronym: SELECT-TBI

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Aug 6, 2021
Registry last updated
Mar 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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