Brain InjuryS100NCT02650765
S100 Biomarker in the Acute Management of Mild Head Injuries
An observational study of Brain Injury and Head Injury, run by Tampere University Hospital at 1 site in Finland.
Trial summary
A prospective validation study of the "Scandinavian guidelines for initial management of minimal, mild and moderate head injuries in adults". Enrolling a consecutive sample of 1000 adult head injury patients from the emergency department of the Tampere University Hospital (Tampere, Finland). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Injury, Head Injury
- What is being tested?
- Indications for head CT imaging after acute head injury
- How many people
- 295 participants
- Where
- 1 siteFinland
- Study dates
- Nov 2015to Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A consecutive sample of adult patients with an acute head injury whom are treated at the emergency department of the Tampere University Hospital, Tampere, Finland
Who may be able to join
- Head injury
Who cannot join
- Age under 18 years
Trial locations and contacts
1 site in 1 country.
About this study
A prospective validation study of the "Scandinavian guidelines for initial management of minimal, mild and moderate head injuries in adults". Enrolling a consecutive sample of 1000 adult head injury patients from the emergency department of the Tampere University Hospital (Tampere, Finland). A venous blood sample with S100 analytics (+storage blood) is drawn from every patient. The patients are head CT-scanned according to the SNC guidelines. Outcome assessment (GOSE, MRS, Rivermead PCS Questionnaire) is completed as follows: 1 week, 6 months, 1 year, and 2 years.
Read the detailed description
A prospective clinical head injury study conducted at the Emergency Department of the Tampere University Hospital, which is situated in Tampere, Finland. The hospital takes care of an catchment area of 524 447 inhabitants both from urban and rural areas. About 100 000 patients are treated in the Emergency department annually.
The study aims to improve the emergency evaluation of patients with an acute head injury, especially a mild head injury. About 80% of head CT scan performed on head injury patients in the Emergency Department of the Tampere University Hospital are negative (= no acute traumatic lesion). There is an urgent need to update the head CT imaging criteria/indications in the context of acute head injury in order to reduce the number of unnecessary scanning. More selective head CT indications result in considerable health care savings and decreased exposure to ionizing radiation, among other benefits.
In this study, the investigators implement the "Scandinavian guidelines for initial management of minimal, mild and moderate head injuries in adults" criteria as part of the emergency care of adults head injury patients. By enrolling a large consecutive sample of patients the investigators are validating this new guideline. Emergency department assessment data is combined with long-term outcome parameters and blood-based biomarkers of neurotrauma.
The main aims of the study are:
- the validation of the Scandinavian guidelines for initial management of minimal, mild and moderate head injuries in adults
- the examination of novel blood-based biomarkers of acute brain injury that correlate with the radiological severity of the injury and the long-term outcome
- Conditions
- Brain Injury, Head Injury
- Being tested
- Indications for head CT imaging after acute head injury
- Keywords
- Brain injury, Head injury, Computed tomography, Emergency department
- Medical subject headings
- Brain Injuries, Craniocerebral Trauma, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indications for head CT imaging after acute head injuryOther
Indications for head CT imaging after acute head injury as per the Scandinavian guidelines for initial management of minimal, mild and moderate head injuries in adults.
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-contrast head CT
Head CT findings: Intracranial traumatic lesions
Measured: 0-72h
Secondary outcomes (3)
Glasgow Outcome Scale Extended
Glasgow Outcome Scale Extended
Measured: 1 week, 6 months, 1 year, and 2 years
Modified Rankin Scale
Modified Rankin Scale
Measured: 1 week, 6 months, 1 year, and 2 years
Rivermead PCS Questionnaire
Rivermead PCS Questionnaire
Measured: 1 week, 6 months, 1 year, and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2016 (estimated)
- Study startNov 2015
- Primary completionFeb 2021
- Study completionFeb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain InjuryStudies of the same condition, open and under way.
- More trials run by Tampere University HospitalThe 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
- Prospective
- Enrolment
- 295 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard Medical School (HMS and HSDM), Turku University Hospital
- Responsible party
- Principal investigator, Teemu Luoto, Tampere University Hospital
- Investigators
- Teemu M Luoto, MD, PhD, Principal investigator, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02650765
- Sponsor's protocol ID
- R15045
- Acronym
- S100
- Status last verified
- Oct 2021
- First submitted
- 22 Dec 2015
- Last updated
- 6 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- S100 Biomarker in the Acute Management of Mild Head Injuries
- ClinicalTrials.gov ID
- NCT02650765
- Acronym / sponsor ID
- S100 / R15045
- Conditions
- Brain Injury, Head Injury
- Keywords
- Brain injury, Head injury, Computed tomography, Emergency department
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 295 participants (actual)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Collaborators
- Harvard Medical School (HMS and HSDM), Turku University Hospital
- Study start
- Nov 2015
- Primary completion
- Feb 2021 (actual)
- Study completion
- Feb 2021 (actual)
- First posted
- 8 Jan 2016 (estimated)
- 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.
A prospective validation study of the "Scandinavian guidelines for initial management of minimal, mild and moderate head injuries in adults". Enrolling a consecutive sample of 1000 adult head injury patients from the emergency department of the Tampere University Hospital (Tampere, Finland). A venous blood sample with S100 analytics (+storage blood) is drawn from every patient. The patients are head CT-scanned according to the SNC guidelines. Outcome assessment (GOSE, MRS, Rivermead PCS Questionnaire) is completed as follows: 1 week, 6 months, 1 year, and 2 years.
Detailed description
A prospective clinical head injury study conducted at the Emergency Department of the Tampere University Hospital, which is situated in Tampere, Finland. The hospital takes care of an catchment area of 524 447 inhabitants both from urban and rural areas. About 100 000 patients are treated in the Emergency department annually.
The study aims to improve the emergency evaluation of patients with an acute head injury, especially a mild head injury. About 80% of head CT scan performed on head injury patients in the Emergency Department of the Tampere University Hospital are negative (= no acute traumatic lesion). There is an urgent need to update the head CT imaging criteria/indications in the context of acute head injury in order to reduce the number of unnecessary scanning. More selective head CT indications result in considerable health care savings and decreased exposure to ionizing radiation, among other benefits.
In this study, the investigators implement the "Scandinavian guidelines for initial management of minimal, mild and moderate head injuries in adults" criteria as part of the emergency care of adults head injury patients. By enrolling a large consecutive sample of patients the investigators are validating this new guideline. Emergency department assessment data is combined with long-term outcome parameters and blood-based biomarkers of neurotrauma.
The main aims of the study are:
- the validation of the Scandinavian guidelines for initial management of minimal, mild and moderate head injuries in adults
- the examination of novel blood-based biomarkers of acute brain injury that correlate with the radiological severity of the injury and the long-term outcome
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A consecutive sample of adult patients with an acute head injury whom are treated at the emergency department of the Tampere University Hospital, Tampere, Finland
Key inclusion criteria (1 listed)
- Head injury
Key exclusion criteria (1 listed)
- Age under 18 years
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 |
|---|---|---|
| Indications for head CT imaging after acute head injuryIndications for head CT imaging after acute head injury as per the Scandinavian guidelines for initial management of minimal, mild and moderate head injuries in adults. | Other | – |
Primary outcome
Non-contrast head CT
Time frame: 0-72h
Head CT findings: Intracranial traumatic lesions
3 secondary outcomes
Glasgow Outcome Scale Extended
Time frame: 1 week, 6 months, 1 year, and 2 years
Modified Rankin Scale
Time frame: 1 week, 6 months, 1 year, and 2 years
Rivermead PCS Questionnaire
Time frame: 1 week, 6 months, 1 year, and 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2021.
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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. This study is not recruiting at the moment.
Teemu M Luoto, MD, PhD principal investigator
Tampere University Hospital
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 Brain Injury and Head Injury, run by Tampere University Hospital at 1 site in Finland.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 6 Oct 2021. 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 Finland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-contrast head CT (time frame: 0-72h). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Oct 2021.