Clinical trial NCT04995068: Score Predicting Lesion Development on CT Following Mild TBI
Official title: Stockholm Score of Lesion Development on Computerized Tomography Following Mild Traumatic Brain Injury
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Traumatic Brain Injury
Mild Traumatic Brain Injury
Keywords: neurosurgery
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Karolinska University Hospital
name: St Goran's Hospital
name: Norrtalje Hospital
name: Danderyd Hospital
name: Sodertalje Hospital
First posted: 2021-08-06
Enrollment: 20000
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults (≥ 15 years) with mild traumatic brain injury (GCS 13-15) who presented to the emergency department within 24 hours of injury.

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.


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

Primary outcomes:
measure: Traumatic intracranial lesion
timeFrame: Immediately after the procedure (CT-scan)
Secondary outcomes:
measure: Clinically significant traumatic intracranial lesion
timeFrame: Immediately after the procedure (CT-scan)
measure: Lesion progression
timeFrame: Within 48 hours of the first CT-scan
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
affiliation: Karolinska Institutet
name: Eric P Thelin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: