NCT04995068 Score Predicting Lesion Development on CT Following Mild TBI
| NCT ID | NCT04995068 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Karolinska Institutet |
| Condition | Traumatic Brain Injury |
| Study Type | OBSERVATIONAL |
| Enrollment | 20,000 participants |
| Start Date | 2021-03-01 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 20,000 participants in total. It began in 2021-03-01 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Eric P Thelin, MD, PhD
PRINCIPAL INVESTIGATOR
Karolinska Institutet
Frequently Asked Questions
Who can join the NCT04995068 clinical trial?
This trial is open to participants of all sexes, aged 15 Years or older, studying Traumatic Brain Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04995068 currently recruiting?
Yes, NCT04995068 is actively recruiting participants. Contact the research team at eric.thelin@ki.se for enrollment information.
Where is the NCT04995068 trial being conducted?
This trial is being conducted at Stockholm, Sweden.
Who is sponsoring the NCT04995068 clinical trial?
NCT04995068 is sponsored by Karolinska Institutet. The principal investigator is Eric P Thelin, MD, PhD at Karolinska Institutet. The trial plans to enroll 20,000 participants.