Validation of the Scandinavian Guidelines for Management of TBI in Adults
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03280485|
Recruitment Status : Recruiting
First Posted : September 12, 2017
Last Update Posted : September 25, 2017
Traumatic brain injuries (TBI) are one of the most common reasons for patients to attend the emergency department (ED). 90% of patients with TBI are defined as mild TBI (mTBI).
A small minority of patients with mTBI would show pathological computed tomography (CT) results and even fewer need neurosurgical intervention. Nevertheless, complications would be so severe, if neurosurgical intervention is delayed, that it has become common practice to subject all patients with mTBI to CT. The high number of CT scans has an impact on health care resources but may also involve risk by subjecting patients through potentially harmful ionizing radiation.
Several independent research groups have attempted to optimize CT use in mTBI patients by forming guidelines that aim to identify patients at high risk for intracranial complications. Most guidelines have been published in the past 15 years and have been validated both prospectively internally and externally; all guidelines have been shown to be safe when implemented in clinical use with few missed complications. However the number of CT scans has not been reduced dramatically, in some cases it has even increased.
In 2013, the new Scandinavian guidelines (SNC13) were published. They are the first guidelines that use a biomarker, S100B, as a tool for managing patients with mTBI. Although S100B has a low specificity for intracranial complications, a high sensitivity makes it suitable to be implemented into clinical practice as a tool for CT reduction. Previous SNC guidelines have been compared to other prominent guidelines with impressive results. The SNC13 have been externally validated in a retrospective study from the USA that was underpowered for important outcomes. Nevertheless, SNC13 have already been partially implemented in clinical practice in Scandinavia. However, a strict multicenter validation has not been performed yet nor a systematic comparison to other available guidelines.
Our primary aim is to validate the performance of the SNC13 in predicting intracranial complications in adult patients presenting with traumatic head injury in Swedish hospitals. A secondary aim is to compare the performance of SNC 13 with 6 other clinical guidelines, with respect to important outcomes. Moreover, to explore the performances of different biomarkers in predicting intracranial complications in predefined subgroups of TBI. Finally, to evaluate the possibility of further improvement of the SNC13.
|Condition or disease||Intervention/treatment|
|Traumatic Brain Injury||Other: no intervention|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||3000 participants|
|Target Follow-Up Duration:||3 Months|
|Official Title:||Multicenter Validation of the Scandinavian Guidelines for Management of Minimal, Mild and Moderate Head Injury in Adults: a Study Protocol.|
|Actual Study Start Date :||September 10, 2017|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||December 31, 2021|
- Other: no intervention
no intervention validation of guidelines via database
- Neurosurgery [ Time Frame: 4 years ]Need for any neurosurgical proceedure or intervention within 1 week of injury
- Intracranial complication [ Time Frame: 4 years ]composite variable of death as consequence of the TBI, need for neurosurgical intervention or marked abnormality on CT
- serious CT findings [ Time Frame: 4 years ]contusions larger than 5mm in diameter, subarachnoid bleeding thicker than 1mm, subdural hematoma thicker than 4mm, pneumocephaly that will need intervention, depressed skull fracture through the inner table.
- CT findings [ Time Frame: 4 years ]Any pathological traumatic CT finding
Biospecimen Retention: Samples Without DNA
A 5ml blood sample is drawn from patient's cubital vein in the ED. Samples are analysed with the fully automated Elecsys® S100 (Roche AB) at the Clinical Chemistry Department of HS, SUS, Örebro University Hospital and Linköping University Hospital, Sweden. Cut-off level for normal levels of S100B according to the SNC guidelines is less than 0.10μg/L and a window of sampling of within 6 hours from the time of the injury.
From all patients seeking care within 24h form injury with medium and low risk TBI, according to SNC13 (including multitrauma patients), a 5ml blood sample will be drawn, centrifuged and frozen at -70 degrees Celsius. Samplings will be coded and registered for analysis of GFAP, SBP-50 and TAU.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03280485
|Contact: Olga Calcagnile, MD, PhDfirstname.lastname@example.org|
|Contact: Johan Undén, PhD, MDemail@example.com|
|Principal Investigator:||Olga Calcagnile, MD, PhD||Halland Hospital Halmstad|