Traumatic Brain INjuryPreTBI IIINCT03062566

Prognostic Potential of Prehospital Biomarkers in TBI Patients

An observational study of Traumatic Brain INjury, run by University of Aarhus at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 100 years
Conditions the study is for: Traumatic Brain INjury
What is being tested?: Blood sampling
How many people: 6 participants
Where: 1 siteDenmark
Study dates: 15 Feb 2017to 1 Feb 2019
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 to 100 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: All adult patients (≥18 years) suffering isolated head trauma and receiving an ambulance dispatched by the Prehospital Emergency Medical Services (EMS) in the Central Denmark Region.

Who may be able to join

Patients presenting with Glasgow Coma Score (GCS) GCS 3-8 suffering relevant trauma and displaying relevant clinical indices compatible with TBI as evaluated by EMS staff. Patients are considered incompetent due to on-going alteration of mental state.

Who cannot join

>6 hours elapsed after trauma, unknown time of trauma, multi trauma, known dementia, chronic psychosis or active central nervous system (CNS) pathology.

Trial locations and contacts

1 site in 1 country.

Denmark1 site

Prehospital Emergency Medical Services, Central Denmark Region
Aarhus N, 8200

Other trials in Denmark

About this study

Official title: Prognostic Potential of Prehospital S100B, Glial Fibrillary Acidic Protein (GFAP) and Neuron Specific Annuals (NSE) Levels in Patients Suffering Severe Traumatic Brain Injury (TBI)

The PreTBI III study aims to investigate the prognostic potential of prehospital and repeated in-hospital S100B, NSE and GFAP measurements as predictors of neurological outcome in patients suffering severe TBI. Knowledge on prehospital S100B, GFAP and NSE levels as predictors of neurological outcome and mortality may underline the potential of a point-of-care analysis. Possibly, the early biomarker levels may contributed to accurate monitoring of biomarker dynamics and hereby support neurosurgeons and anaesthetists in the clinical decision-making regarding treatment and level of care offered to the patient.

Hypotheses:

Prehospital S100B level is a significant predictor of unfavourable neurological outcome (dichotomized disability rating scale (DRS) and glasgow outcome scale extended (GOS-E) measures) in severe TBI patients.
Prehospital GFAP level is a significant predictor of unfavourable neurological outcome (dichotomized DRS and GOSE measures) in severe TBI patients.
Prehospital NSE level is a significant predictor of unfavourable neurological outcome (dichotomized DRS and GOSE measures) in severe TBI patients.
combined panel of prehospital S100B, GFAP and NSE levels is a significant predictor of unfavourable neurological outcome (dichotomized DRS and GOSE measures) in severe TBI patients.
Unfavourable neurological outcome (dichotomized DRS and GOSE measures) in severe TBI patients can be predicted by dynamics in repeated measurements of S100B, GFAP and NSE.

Conditions: Traumatic Brain INjury
Being tested: Blood sampling
Keywords: biomarkers, point-of-care analysis
Medical subject headings: Brain Injuries, Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Blood samplingOther
Blood sampling from peripheral venous catheter routinely inserted in trauma patients during transportation

Study groups in NCT03062566
Study group	Role	What they receive
Severe TBI patients		GCS 3-8 Receives: Other: Blood sampling

What is being measured

The primary outcome is the main question the study is designed to answer.

Sensitivity of se-S100B in relation to a binary outcome measured by by a yes/no question of "favorable neurological outcome" pick favorable/unfavorable
Neurological outcome will be evaluated by a dichotomized glasgow outcome score extended (GOSE) as "Favorable (GOSE 5-8)/Unfavorable (GOSE 1-4)
Measured: in relation to event within 1 year
Specificity of se-S100B in relation to a binary outcome measured by by a yes/no question of "favorable neurological outcome" pick favorable/unfavorable
Neurological outcome will be evaluated by a dichotomized glasgow outcome score extended (GOSE) as "Favorable (GOSE 5-8)/Unfavorable (GOSE 1-4)
Measured: in relation to event within 1 year
Positive predictive value of se-S100B in relation to a binary outcome measured by by a yes/no question of "favorable neurological outcome" pick favorable/unfavorable
Neurological outcome will be evaluated by a dichotomized glasgow outcome score extended (GOSE) as "Favorable (GOSE 5-8)/Unfavorable (GOSE 1-4)
Measured: in relation to event within 1 year
Negative predictive value of se-S100B in relation to a binary outcome measured by by a yes/no question of "favorable neurological outcome" pick favorable/unfavorable
Neurological outcome will be evaluated by a dichotomized glasgow outcome score extended (GOSE) as "Favorable (GOSE 5-8)/Unfavorable (GOSE 1-4)
Measured: in relation to event within 1 year

Secondary outcomes (8)

Sensitivity of se-GFAP in relation to a binary outcome measured by by a yes/no question of "favorable neurological outcome" pick favorable/unfavorable
Neurological outcome will be evaluated by a dichotomized glasgow outcome score extended (GOSE) as "Favorable (GOSE 5-8)/Unfavorable (GOSE 1-4)
Measured: in relation to event within 1 year
Specificity of se-GFAP in relation to a binary outcome measured by by a yes/no question of "favorable neurological outcome" pick favorable/unfavorable
Neurological outcome will be evaluated by a dichotomized glasgow outcome score extended (GOSE) as "Favorable (GOSE 5-8)/Unfavorable (GOSE 1-4)
Measured: in relation to event within 1 year of trauma
Positive predictive value of se-GFAP in relation to a binary outcome measured by by a yes/no question of "favorable neurological outcome" pick favorable/unfavorable
Neurological outcome will be evaluated by a dichotomized glasgow outcome score extended (GOSE) as "Favorable (GOSE 5-8)/Unfavorable (GOSE 1-4)
Measured: in relation to event within 1 year of trauma
Negative predictive value of se-GFAP in relation to a binary outcome measured by by a yes/no question of "favorable neurological outcome" pick favorable/unfavorable
Neurological outcome will be evaluated by a dichotomized glasgow outcome score extended (GOSE) as "Favorable (GOSE 5-8)/Unfavorable (GOSE 1-4)
Measured: in relation to event within 1 year of trauma
Sensitivity of se-NSE in relation to a binary outcome measured by by a yes/no question of "favorable neurological outcome" pick favorable/unfavorable
Neurological outcome will be evaluated by a dichotomized glasgow outcome score extended (GOSE) as "Favorable (GOSE 5-8)/Unfavorable (GOSE 1-4)
Measured: in relation to event within 1 year of trauma
Specificity of se-NSE in relation to a binary outcome measured by by a yes/no question of "favorable neurological outcome" pick favorable/unfavorable
Neurological outcome will be evaluated by a dichotomized glasgow outcome score extended (GOSE) as "Favorable (GOSE 5-8)/Unfavorable (GOSE 1-4)
Measured: in relation to event within 1 year of trauma
Positive predictive value of se-NSE in relation to a binary outcome measured by by a yes/no question of "favorable neurological outcome" pick favorable/unfavorable
Neurological outcome will be evaluated by a dichotomized glasgow outcome score extended (GOSE) as "Favorable (GOSE 5-8)/Unfavorable (GOSE 1-4)
Measured: in relation to event within 1 year of trauma
Negative predictive value of se-NSE in relation to a binary outcome measured by by a yes/no question of "favorable neurological outcome" pick favorable/unfavorable
Neurological outcome will be evaluated by a dichotomized glasgow outcome score extended (GOSE) as "Favorable (GOSE 5-8)/Unfavorable (GOSE 1-4)
Measured: in relation to event within 1 year of trauma

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Feb 20171 Feb 2019

First posted23 Feb 2017
Study start15 Feb 2017
Primary completion1 Feb 2019
Study completion1 Feb 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Traumatic Brain INjuryStudies of the same condition, open and under way.
More trials run by University of AarhusThe 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: 6 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03062566
Sponsor's protocol ID: Protokol_v3_240816_PreTBI_III
Acronym: PreTBI III
Status last verified: May 2018
First submitted: 21 Nov 2016
Last updated: 24 Apr 2019
Results posted: No
Data monitoring committee: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
Enrolling by invitationPhase 1
Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
Mild Traumatic Brain Injury
RecruitingObservational study
Intracranial Pressure Monitoring in Moderate Traumatic Brain Injury
Moderate Traumatic Brain Injury
Not yet recruitingPhase 1
Nanopulse Laser Therapy
TBI (Traumatic Brain Injury)
RecruitingObservational study
Effect of Different Intravenous Fluids on Post-operative Chronic Subdural Hematoma Size and Recurrence
Chronic Subdural Hematoma

All Traumatic Brain INjury trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prognostic Potential of Prehospital S100B, Glial Fibrillary Acidic Protein (GFAP) and Neuron Specific Annuals (NSE) Levels in Patients Suffering Severe Traumatic Brain Injury (TBI)
ClinicalTrials.gov ID: NCT03062566
Acronym / sponsor ID: PreTBI III / Protokol_v3_240816_PreTBI_III
Conditions: Traumatic Brain INjury
Keywords: biomarkers, point-of-care analysis
Study type: Observational
Recruitment status: Completed
Enrolment: 6 participants (actual)
Lead sponsor: University of AarhusUniversity, hospital or other
Collaborators: Central Denmark Region, Aarhus University Hospital
Study start: 15 Feb 2017 (actual)
Primary completion: 1 Feb 2019 (actual)
Study completion: 1 Feb 2019 (actual)
First posted: 23 Feb 2017 (actual)
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.

Hypotheses:

Prehospital S100B level is a significant predictor of unfavourable neurological outcome (dichotomized disability rating scale (DRS) and glasgow outcome scale extended (GOS-E) measures) in severe TBI patients.
Prehospital GFAP level is a significant predictor of unfavourable neurological outcome (dichotomized DRS and GOSE measures) in severe TBI patients.
Prehospital NSE level is a significant predictor of unfavourable neurological outcome (dichotomized DRS and GOSE measures) in severe TBI patients.
combined panel of prehospital S100B, GFAP and NSE levels is a significant predictor of unfavourable neurological outcome (dichotomized DRS and GOSE measures) in severe TBI patients.
Unfavourable neurological outcome (dichotomized DRS and GOSE measures) in severe TBI patients can be predicted by dynamics in repeated measurements of S100B, GFAP and NSE.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Severe TBI patients	–	Other: Blood samplingGCS 3-8

Who may qualify

Ages: 18 to 100 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: All adult patients (≥18 years) suffering isolated head trauma and receiving an ambulance dispatched by the Prehospital Emergency Medical Services (EMS) in the Central Denmark Region.

Key inclusion criteria (1 listed)

Patients presenting with Glasgow Coma Score (GCS) GCS 3-8 suffering relevant trauma and displaying relevant clinical indices compatible with TBI as evaluated by EMS staff. Patients are considered incompetent due to on-going alteration of mental state.

Key exclusion criteria (1 listed)

>6 hours elapsed after trauma, unknown time of trauma, multi trauma, known dementia, chronic psychosis or active central nervous system (CNS) pathology.

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
Blood samplingBlood sampling from peripheral venous catheter routinely inserted in trauma patients during transportation	Other	Severe TBI patients

Primary outcome

Sensitivity of se-S100B in relation to a binary outcome measured by by a yes/no question of "favorable neurological outcome" pick favorable/unfavorable
Time frame: in relation to event within 1 year
Neurological outcome will be evaluated by a dichotomized glasgow outcome score extended (GOSE) as "Favorable (GOSE 5-8)/Unfavorable (GOSE 1-4)
Specificity of se-S100B in relation to a binary outcome measured by by a yes/no question of "favorable neurological outcome" pick favorable/unfavorable
Time frame: in relation to event within 1 year
Neurological outcome will be evaluated by a dichotomized glasgow outcome score extended (GOSE) as "Favorable (GOSE 5-8)/Unfavorable (GOSE 1-4)
Positive predictive value of se-S100B in relation to a binary outcome measured by by a yes/no question of "favorable neurological outcome" pick favorable/unfavorable
Time frame: in relation to event within 1 year
Neurological outcome will be evaluated by a dichotomized glasgow outcome score extended (GOSE) as "Favorable (GOSE 5-8)/Unfavorable (GOSE 1-4)
Negative predictive value of se-S100B in relation to a binary outcome measured by by a yes/no question of "favorable neurological outcome" pick favorable/unfavorable
Time frame: in relation to event within 1 year
Neurological outcome will be evaluated by a dichotomized glasgow outcome score extended (GOSE) as "Favorable (GOSE 5-8)/Unfavorable (GOSE 1-4)

8 secondary outcomes

Sensitivity of se-GFAP in relation to a binary outcome measured by by a yes/no question of "favorable neurological outcome" pick favorable/unfavorable
Time frame: in relation to event within 1 year
Specificity of se-GFAP in relation to a binary outcome measured by by a yes/no question of "favorable neurological outcome" pick favorable/unfavorable
Time frame: in relation to event within 1 year of trauma
Positive predictive value of se-GFAP in relation to a binary outcome measured by by a yes/no question of "favorable neurological outcome" pick favorable/unfavorable
Time frame: in relation to event within 1 year of trauma
Negative predictive value of se-GFAP in relation to a binary outcome measured by by a yes/no question of "favorable neurological outcome" pick favorable/unfavorable
Time frame: in relation to event within 1 year of trauma
Sensitivity of se-NSE in relation to a binary outcome measured by by a yes/no question of "favorable neurological outcome" pick favorable/unfavorable
Time frame: in relation to event within 1 year of trauma
Specificity of se-NSE in relation to a binary outcome measured by by a yes/no question of "favorable neurological outcome" pick favorable/unfavorable
Time frame: in relation to event within 1 year of trauma
Positive predictive value of se-NSE in relation to a binary outcome measured by by a yes/no question of "favorable neurological outcome" pick favorable/unfavorable
Time frame: in relation to event within 1 year of trauma
Negative predictive value of se-NSE in relation to a binary outcome measured by by a yes/no question of "favorable neurological outcome" pick favorable/unfavorable
Time frame: in relation to event within 1 year of trauma

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 24 Apr 2019.
Individual participant dataSharing planned: No

Related trials for Traumatic Brain INjury

Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
Enrolling by invitationPhase 1
Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
Mild Traumatic Brain Injury
RecruitingObservational study
Intracranial Pressure Monitoring in Moderate Traumatic Brain Injury
Moderate Traumatic Brain Injury
Not yet recruitingPhase 1
Nanopulse Laser Therapy
TBI (Traumatic Brain Injury)
RecruitingObservational study
Effect of Different Intravenous Fluids on Post-operative Chronic Subdural Hematoma Size and Recurrence
Chronic Subdural Hematoma

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.

The record lists no contact. Use the official record to reach the sponsor.

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 Traumatic Brain INjury, run by University of Aarhus at 1 site in Denmark.

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 24 Apr 2019. 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 Denmark. 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?

Sensitivity of se-S100B in relation to a binary outcome measured by by a yes/no question of "favorable neurological outcome" pick favorable/unfavorable (time frame: in relation to event within 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03062566.

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 24 Apr 2019.