Score Predicting Lesion Development on CT Following Mild TBI

Официальное название

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

Обзор

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.

Вмешательства

• Лучевая терапия Head CT to determine presence of traumatic intracranial lesion
  Head CT to determine presence of traumatic intracranial lesion

Первичные конечные точки

• Traumatic intracranial lesion [Срок оценки: Immediately after the procedure (CT-scan)]

Вторичные конечные точки (2)

• Clinically significant traumatic intracranial lesion [Срок оценки: Immediately after the procedure (CT-scan)]
• Lesion progression [Срок оценки: Within 48 hours of the first CT-scan]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Швеция · 1 центр

• Karolinska University Hospital — Stockholm

Публикации

• 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 Neuroch PMID 40591064
• 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 Ope PMID 36581962

Идентификаторы

NCT: NCT04995068 · 2020-05728

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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