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Score Predicting Lesion Development on CT Following Mild TBI

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04995068
Acronym
SELECT-TBI
Enrollment
20000
Registered
2021-08-06
Start date
2021-03-01
Completion date
2025-12-31
Last updated
2025-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild Traumatic Brain Injury, Traumatic Brain Injury

Keywords

neurosurgery

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.

Interventions

RADIATIONHead CT to determine presence of traumatic intracranial lesion

Head CT to determine presence of traumatic intracranial lesion

Sponsors

Karolinska University Hospital
CollaboratorOTHER
St Goran's Hospital
CollaboratorOTHER
Norrtalje Hospital
CollaboratorUNKNOWN
Danderyd Hospital
CollaboratorOTHER
Sodertalje Hospital
CollaboratorOTHER
Karolinska Institutet
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Traumatic intracranial lesionImmediately 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

MeasureTime frameDescription
Clinically significant traumatic intracranial lesionImmediately 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
Lesion progressionWithin 48 hours of the first CT-scanHemorrhagic primary outcome measure (cerebral contusion, subdural haematoma, epidural haematoma, subarachnoid haemorrhage or intraventricular haemorrhage) that progressed on a follow-up CT

Countries

Sweden

Contacts

Primary ContactEric P Thelin, MD, PhD
eric.thelin@ki.se0046739365450
Backup ContactAlexander Fletcher-Sandersjöö, MD
alexander.fletcher-sandersjoo@ki.se

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026