Score Predicting Lesion Development on CT Following Mild TBI

NCT04995068 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 20000

Last updated 2025-03-10

No results posted yet for this study

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.

Conditions

Interventions

RADIATION

Head CT to determine presence of traumatic intracranial lesion

Head CT to determine presence of traumatic intracranial lesion

Sponsors & Collaborators

  • Karolinska University Hospital

    collaborator OTHER
  • St Goran's Hospital

    collaborator OTHER
  • Norrtalje Hospital

    collaborator UNKNOWN
  • Danderyd Hospital

    collaborator OTHER
  • Sodertalje Hospital

    collaborator OTHER
  • Karolinska Institutet

    lead OTHER

Principal Investigators

  • Eric P Thelin, MD, PhD · Karolinska Institutet

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-01
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Sweden

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04995068 on ClinicalTrials.gov