Predicting brain injury complications after mild trauma
Stockholm Score of Lesion Development on Computerized Tomography Following Mild Traumatic Brain Injury
This study is trying to create a scoring system to help doctors predict which adults with mild brain injuries might develop serious complications and need surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20000 (estimated) |
| Ages | 15 Years and up |
| Sex | All |
| Sponsor | Karolinska Institutet Academic / other |
| Locations | 1 site (Stockholm) |
| Trial ID | NCT04995068 on ClinicalTrials.gov |
What this trial studies
This observational study aims to develop a risk stratification score to predict the likelihood of intracranial lesion development and the need for neurosurgical intervention in patients with mild traumatic brain injury (mTBI). It focuses on adults who present to the emergency department within 24 hours of injury and have a Glasgow Coma Scale score of 13-15. By analyzing data from patients treated in Stockholm, Sweden, the study seeks to improve the specificity of existing guidelines for CT scanning in mTBI cases.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 15 and older who have experienced mild traumatic brain injury and presented to the emergency department within 24 hours.
Not a fit: Patients who have not undergone a CT scan or those with penetrating traumatic brain injuries will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the decision-making process for emergency departments, potentially reducing unnecessary CT scans and improving patient outcomes.
How similar studies have performed: While there have been studies on mTBI, this specific approach to developing a predictive score for lesion development is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Stockholm
- Karolinska University Hospital — Stockholm, Sweden (Recruiting)
Study contacts
- Principal investigator: Eric P Thelin, MD, PhD — Karolinska Institutet
- Study coordinator: Eric P Thelin, MD, PhD
- Email: eric.thelin@ki.se
- Phone: 0046739365450
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.