Traumatic Brain InjurySELECT-TBINCT04995068
Score Predicting Lesion Development on CT Following Mild TBI
An observational study of Traumatic Brain Injury and Mild Traumatic Brain Injury, run by Karolinska Institutet at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Traumatic Brain Injury, Mild Traumatic Brain Injury
- What is being tested?
- Head CT to determine presence of traumatic intracranial lesion
- Type of treatment
- Surgery or procedure
- How many people
- 20,000 participants
- Where
- 1 siteSweden
- Study dates
- 1 Mar 2021to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adults (≥ 15 years) with mild traumatic brain injury (GCS 13-15) who presented to the emergency department within 24 hours of injury.
Who may be able to join
- Adult (≥ 15 years)
- Presented to emergency department within 24 hours of TBI
- GCS 13-15 at presentation to the emergency department
Who cannot join
- No CT scan performed
- Patient from another Region in Sweden/another country
- Penetrating TBI
- Secondary transfer from other emergency department
- Medical record missing
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Alexander Fletcher-Sandersjöö, MD contact
Sweden1 site, 1 recruiting
- Recruiting
Karolinska University Hospital
Stockholm
Eric P Thelin, MD, 0046739365450, eric.thelin@ki.se
About this study
Official title: Stockholm Score of Lesion Development on Computerized Tomography Following Mild Traumatic Brain Injury
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.
- Being tested
- Head CT to determine presence of traumatic intracranial lesion
- Keywords
- neurosurgery
- Medical subject headings
- Brain Injuries, Traumatic, Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Head CT to determine presence of traumatic intracranial lesionRadiation
Head CT to determine presence of traumatic intracranial lesion
| Study group | Role | What they receive |
|---|---|---|
| Included patients | See inclusion and exclusion criteria Receives: Radiation: Head CT to determine presence of traumatic intracranial lesion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately after the procedure (CT-scan)
Secondary outcomes (2)
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
Measured: Immediately after the procedure (CT-scan)
Lesion progression
Hemorrhagic primary outcome measure (cerebral contusion, subdural haematoma, epidural haematoma, subarachnoid haemorrhage or intraventricular haemorrhage) that progressed on a follow-up CT
Measured: Within 48 hours of the first CT-scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2021
- Study start1 Mar 2021
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 20,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska University Hospital, St Goran's Hospital, Norrtalje Hospital, Danderyd Hospital, Sodertalje Hospital
- Responsible party
- Principal investigator, Eric Thelin, Karolinska Institutet
- Investigators
- Eric P Thelin, MD, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04995068
- Sponsor's protocol ID
- 2020-05728
- Acronym
- SELECT-TBI
- Status last verified
- Oct 2024
- First submitted
- 27 Jul 2021
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The datasets used and/or analyzed during the planned study will be available from the corresponding author on reasonable request.
Publications
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.
PubMed 40591064Fletcher-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.
PubMed 36581962
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stockholm Score of Lesion Development on Computerized Tomography Following Mild Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT04995068
- Acronym / sponsor ID
- SELECT-TBI / 2020-05728
- Keywords
- neurosurgery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Karolinska University Hospital, St Goran's Hospital, Norrtalje Hospital, Danderyd Hospital, Sodertalje Hospital
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 6 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Included patients | – | Radiation: Head CT to determine presence of traumatic intracranial lesionSee inclusion and exclusion criteria |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adults (≥ 15 years) with mild traumatic brain injury (GCS 13-15) who presented to the emergency department within 24 hours of injury.
Key inclusion criteria (3 listed)
- Adult (≥ 15 years)
- Presented to emergency department within 24 hours of TBI
- GCS 13-15 at presentation to the emergency department
Key exclusion criteria (5 listed)
- No CT scan performed
- Patient from another Region in Sweden/another country
- Penetrating TBI
- Secondary transfer from other emergency department
- Medical record missing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Head CT to determine presence of traumatic intracranial lesionHead CT to determine presence of traumatic intracranial lesion | Radiation | Included patients |
Primary outcome
Traumatic intracranial lesion
Time frame: Immediately after the procedure (CT-scan)
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.
2 secondary outcomes
Clinically significant traumatic intracranial lesion
Time frame: Immediately after the procedure (CT-scan)
Lesion progression
Time frame: Within 48 hours of the first CT-scan
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
- Derived from this study: PubMed 40591064Yang 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.
- Derived from this study: PubMed 36581962Fletcher-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.
- Individual participant dataSharing planned: Yes. The datasets used and/or analyzed during the planned study will be available from the corresponding author on reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alexander Fletcher-Sandersjöö, MD contact
Eric P Thelin, MD, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury and Mild Traumatic Brain Injury, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eric P Thelin, MD, PhD (0046739365450, eric.thelin@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Traumatic intracranial lesion (time frame: Immediately after the procedure (CT-scan)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04995068, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2025.