Validation of the Scandinavian Guidelines for Management of TBI in Adults

NCT03280485 | Unknown

• 1 other identifier: no number
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Brain Injury

Keywords

TBI; management; S100B; biomarkers; mild head injury; intracranial complication

Outcome Measures

Primary Outcomes (2)

• Neurosurgery

  Need for any neurosurgical proceedure or intervention within 1 week of injury

  4 years

• Intracranial complication

  composite variable of death as consequence of the TBI, need for neurosurgical intervention or marked abnormality on CT

  4 years

Secondary Outcomes (2)

• serious CT findings

  4 years

• CT findings

  4 years

Interventions

no intervention OTHER

no intervention validation of guidelines via database

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

adults with TBI

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Halmstad County Hospital: lead

Study Sites (1)

Halland Hospital Halmstad

Halmstad, 302 64, Sweden

RECRUITING

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.

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Olga Calcagnile, MD, PhD

  Halland Hospital Halmstad

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Olga Calcagnile, MD, PhD

CONTACT

004635131000; olga.calcagnile@regionhalland.se

Johan Undén, PhD, MD

CONTACT

004635131000; johan.unden@regionhalland.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor, PhD

Study Record Dates

• First Submitted: August 28, 2017
• First Posted: September 12, 2017
• Study Start: September 10, 2017
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2021
• Last Updated: September 25, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)