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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. Identifier: NCT03280485
Recruitment Status : Recruiting
First Posted : September 12, 2017
Last Update Posted : September 25, 2017
Information provided by (Responsible Party):
Olga Calcagnile, Halmstad County Hospital

Brief Summary:

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

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Head Injuries

Intervention Details:
  • Other: no intervention
    no intervention validation of guidelines via database

Primary Outcome Measures :
  1. Neurosurgery [ Time Frame: 4 years ]
    Need for any neurosurgical proceedure or intervention within 1 week of injury

  2. Intracranial complication [ Time Frame: 4 years ]
    composite variable of death as consequence of the TBI, need for neurosurgical intervention or marked abnormality on CT

Secondary Outcome Measures :
  1. 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.

  2. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
adults with TBI

Inclusion Criteria:

  • From September 2017 we will prospectively enroll all adult patients with a GCS 9-15 that seek the ED in Halmstad, Malmo, Lund, Linkoping, Orebro (Sweden) within 24h after TBI.

Exclusion criteria

We will exclude:

  • patients younger than 18 years of age;
  • patients without a Swedish personal identification number due to difficulties in performing the follow up phase;
  • all patients that refuse to participate.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03280485

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Contact: Olga Calcagnile, MD, PhD 004635131000
Contact: Johan Undén, PhD, MD 004635131000

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Halland Hospital Halmstad Recruiting
Halmstad, Sweden, 302 64
Contact: Olga Calcagnile, MD, PhD    035-131000   
Contact: Johan Undén, PhD, MD    035-131000   
Sponsors and Collaborators
Halmstad County Hospital
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Principal Investigator: Olga Calcagnile, MD, PhD Halland Hospital Halmstad
  Study Documents (Full-Text)

Documents provided by Olga Calcagnile, Halmstad County Hospital:
Study Protocol  [PDF] August 30, 2017

Additional Information:

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Responsible Party: Olga Calcagnile, Medical doctor, PhD, Halmstad County Hospital Identifier: NCT03280485    
Other Study ID Numbers: no number
First Posted: September 12, 2017    Key Record Dates
Last Update Posted: September 25, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Olga Calcagnile, Halmstad County Hospital:
mild head injury
intracranial complication
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System