Score Predicting Lesion Development on CT Following Mild TBI

Traumatic Brain Injury Clinical Trial

— SELECT-TBI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04995068
• Other study ID #: 2020-05728
• Status: Recruiting
• Start date: March 1, 2021
• Est. completion date: June 1, 2024

Study information

• Verified date: March 2023
• Source: Karolinska Institutet
• Contact: Eric P Thelin, MD, PhD
• Phone: 0046739365450
• Email: eric.thelin[@]ki.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20000
• Est. completion date: June 1, 2024
• Est. primary completion date: December 31, 2023
• Gender: All
• Age group: 15 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• Mild Traumatic Brain Injury
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

Radiation:
• Head CT to determine presence of traumatic intracranial lesion
Head CT to determine presence of traumatic intracranial lesion

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital	Stockholm

Sponsors (7)

Lead Sponsor	Collaborator
Karolinska Institutet	Danderyd Hospital, Karolinska University Hospital, Norrtalje Hospital, Sodertalje Hospital, St Goran's Hospital, Stockholm South General Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Traumatic intracranial lesion	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.	Immediately after the procedure (CT-scan)
Secondary	Clinically significant traumatic intracranial lesion	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	Immediately after the procedure (CT-scan)
Secondary	Lesion progression	Hemorrhagic primary outcome measure (cerebral contusion, subdural haematoma, epidural haematoma, subarachnoid haemorrhage or intraventricular haemorrhage) that progressed on a follow-up CT	Within 48 hours of the first CT-scan