Score Predicting Lesion Development on CT Following Mild TBI

NCT04995068 | Recruiting

• 1 other identifier: 2020-05728
• Study Type: observational
• Target: 20,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Brain Injury; Mild Traumatic Brain Injury

Keywords

neurosurgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Clinically significant traumatic intracranial lesion

  Immediately after the procedure (CT-scan)

• Lesion progression

  Within 48 hours of the first CT-scan

Study Arms (1)

Included patients

See inclusion and exclusion criteria

Radiation: Head CT to determine presence of traumatic intracranial lesion

Interventions

Head CT to determine presence of traumatic intracranial lesion RADIATION

Head CT to determine presence of traumatic intracranial lesion

Included patients

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Adult (≥ 15 years)
• Presented to emergency department within 24 hours of TBI
• GCS 13-15 at presentation to the emergency department

You may not qualify if:

• No CT scan performed
• Patient from another Region in Sweden/another country
• Penetrating TBI
• Secondary transfer from other emergency department
• Medical record missing

Sponsors & Collaborators

• Karolinska Institutet: lead
• Karolinska University Hospital: collaborator
• St Goran's Hospital: collaborator
• Norrtalje Hospital: collaborator
• Danderyd Hospital: collaborator
• Sodertalje Hospital: collaborator

Study Sites (1)

Karolinska University Hospital

Stockholm, Sweden

RECRUITING

Related Publications (2)

• Yang LJ, Tatter C, Fletcher-Sandersjoo A, Froese L, Lassaren P, Tjerkaski J, Bergman EE, Bjorkman FE, Bronge J, Antonsson J, Teromaa K, Nylander M, Ortqvist S, Kylander W, Lindqvist W, Angeby K, Rubenson Wahlin R, Thelin EP. Stockholm Score of Lesion Detection on Computed Tomography following Mild Traumatic Brain Injury (SELECT-TBI) Study: Pilot Analysis and Statistical Analysis Plan. Acta Neurochir (Wien). 2025 Jul 1;167(1):181. doi: 10.1007/s00701-025-06598-1.

  PMID: 40591064 DERIVED

• Fletcher-Sandersjoo A, Tatter C, Yang L, Ponten E, Boman M, Lassaren P, Forsberg S, Gronlund I, Tidehag V, Rubenson-Wahlin R, Strommer L, Westberg K, Angeby K, Djarv T, Lundblad O, Bartek J Jr, Thelin EP. Stockholm score of lesion detection on computed tomography following mild traumatic brain injury (SELECT-TBI): study protocol for a multicentre, retrospective, observational cohort study. BMJ Open. 2022 Sep 1;12(9):e060679. doi: 10.1136/bmjopen-2021-060679.

  PMID: 36581962 DERIVED

MeSH Terms

Conditions

Brain Injuries, Traumatic; Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Head Injuries, Closed; Wounds, Nonpenetrating

Study Officials

• Eric P Thelin, MD, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eric P Thelin, MD, PhD

CONTACT

0046739365450; eric.thelin@ki.se

Alexander Fletcher-Sandersjöö, MD

CONTACT

alexander.fletcher-sandersjoo@ki.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: July 27, 2021
• First Posted: August 6, 2021
• Study Start: March 1, 2021
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 10, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Following publication of the study, the above will be available from the corresponding author on reasonable request.

Locations

SE (1)