Brain Injury Traumatic Severe (Diagnosis)NCT05138692
Biomarkers and Outcome 1 and 10-15 Years After Severe Traumatic Brain Injury
An observational study of Brain Injury Traumatic Severe (Diagnosis) and Biomarkers, run by Bengt Nellgard at 1 site in Sweden.
Trial summary
After written consent from next-of-kin patients with severe traumatic brain injury was included from the neurointensive care unit (NICU) at Sahlgrenska university hospital, Gothenburg. Blood and CSF samples were collected during the initial 3 weeks after trauma. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Brain Injury Traumatic Severe (Diagnosis), Biomarkers
- How many people
- 99 participants
- Where
- 1 siteSweden
- Study dates
- 1 Oct 2000to 1 Dec 2016
- How long will I take part?
- 15 Years
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Patient with severe traumatic brain injury, defined by our inclusion criteria, where enrolled from the Neurointensive care unit at Sahlgrenska university hospital, Gothenburg. Sahlgrenska University hospital is a tertiary hospital admitting patients from the whole south west part of Sweden.
Who may be able to join
- Reaction level scale >3, corresponding to a Glasgow coma scale <9
- A therapeutic indication for intracranial pressure monitoring
- Need for ventilator treatment
Who cannot join
- Not residing in Sweden
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Sahlgrenska University Hospital
Mölndal, Västra Götaland County, 431 80
About this study
Official title: The Association Between Initial Concentrations of Biomarkers and Outcome 1 and 10-15 Years After Severe Traumatic Brain Injury
After written consent from next-of-kin patients with severe traumatic brain injury was included from the neurointensive care unit (NICU) at Sahlgrenska university hospital, Gothenburg. Blood and CSF samples were collected during the initial 3 weeks after trauma. 1 year after trauma patients were assessed according to Glasgow outcome scale (GOS), NIHSS and Barthels. 10-15 years after trauma a repeated evaluation according to GOS was performed by telephone. Different biomarkers such as Neurofilament light, Glial fibrillary acidic protein and Tau among others, was analyzed from serum and CSF samples. Further patients were explored Apolipoprotein-E genetype (APOE). The investigators hypothesize that higher biomarkers concentrations and positive test for this gene relate to worse outcome 1-year and 10-15 years after trauma. Further that these biomarkers and genetic marker further have prognostic value on outcome 1-year and 10-15 years after trauma. Finally, the investigators want to explore the concentrations dynamics of these biomarkers in serum and CSF in the acute phase after trauma.
Read the detailed description
Patients with a severe traumatic brain injury (sTBI) were included after written consent from next-to kin. The injury was considered as severe if having a Glasgow coma scale of 8 or less. Within 48h of trauma patients were included from the neurointensive care unit at Sahlgrenska university hospital, Gothenburg during 2000-2004. Patients were intubated and had a ventricular catheter. All patients were treated in accordance with the Lund Concept. Samples from ventricular cerebrospinal fluid (CSF) and blood was collected, during the first 3 weeks, then prepared for storage and later analyzed. Samples were stored in -70 degrees Celsius until analyzed. 1 year after trauma patients were assessed according to Glasgow outcome scale (GOS), NIHSS and Barthels Index. 10-15 years after trauma an evaluation of GOS by phone was repeated. Biomarkers such as Neurofilament light, Glial fibrillary acidic protein, Tau among others is analyzed in serum and CSF. Further, patients APOE genotype was explored. The investigators hypothesizes that higher concentrations of these biomarkers both in serum and CSF relate to worse 1-year and 10-15 year outcome after a severe traumatic brain injury. Further, patients that have the gene APOE4 is predisposed to worse 1 year and 10-15 year outcome after a sTBI. The investigators further want to explore the dynamics of these biomarkers in serum and CSF in the acute phase after trauma and if these biomarkers gave any prognostic value to on outcome (mortality and functional) 1-year and 10-15 years after trauma.
- Medical subject headings
- Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
In severe traumatic brain injury patient; Correlation of Neurochemical biomarkers analyzed in CSF and serum, assessed in the initial ICU period, correlated to Glasgow Outcome Scale (GOS) at 1 year post-trauma
GOS 1-3 - Poor outcome, GOS 4-5 Good outcome
Measured: 1 year after trauma
In severe traumatic brain injury patient; Correlation of Neurochemical biomarkers analyzed in CSF and serum, assessed in the initial ICU period, correlated to Glasgow Outcome Scale (GOS) at 10-15 years post-trauma
GOS 1-3 - Poor outcome, GOS 4-5 Good outcome
Measured: 10-15 years after trauma
In severe traumatic brain injury patient; correlation of the genetic alleles of APOE correlated to Glasgow Outcome Scale (GOS) at 1-year post-trauma)
GOS 1-3 - Poor outcome, GOS 4-5 Good outcome
Measured: 1 year after trauma
In severe traumatic brain injury patient; correlation of the genetic alleles of APOE correlated to Glasgow Outcome Scale (GOS) at 10-15 years post-trauma)
GOS 1-3 - Poor outcome, GOS 4-5 Good outcome
Measured: 10-15 years after trauma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start1 Oct 2000
- Primary completion1 Dec 2016
- Study completion1 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brain Injury Traumatic Severe (Diagnosis)Studies of the same condition, open and under way.
- 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
- 99 participants (actual)
- Target duration
- 15 Years
Sponsor and investigators
- Lead sponsor
- Bengt Nellgard
- Sponsor type
- University, hospital or other
- Collaborators
- Svenska alzheimerfonden, Stroke Foundation
- Responsible party
- Sponsor-investigator, Bengt Nellgard, Sahlgrenska University Hospital
- Investigators
- Bengt Nellgård, MD PhD Professor, Study director, University of Gothenburg and Västra götaland Regionen, Sahlgrenska Universitetssjukhus Mölndal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05138692
- Sponsor's protocol ID
- Neuromarkers and neurotrauma
- Status last verified
- Nov 2021
- First submitted
- 18 Nov 2021
- Last updated
- 1 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Andersson E, Ost M, Dalla K, Zetterberg H, Blennow K, Nellgard B. Acute-Phase Neurofilament Light and Glial Fibrillary Acidic Proteins in Cerebrospinal Fluid Predict Long-Term Outcome After Severe Traumatic Brain Injury. Neurocrit Care. 2024 Dec;41(3):813-827. doi: 10.1007/s12028-024-01998-0. Epub 2024 May 20.
PubMed 38769253
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Initial Concentrations of Biomarkers and Outcome 1 and 10-15 Years After Severe Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT05138692
- Acronym / sponsor ID
- Neuromarkers and neurotrauma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Bengt NellgardUniversity, hospital or other
- Collaborators
- Svenska alzheimerfonden, Stroke Foundation
- Study start
- 1 Oct 2000 (actual)
- Primary completion
- 1 Dec 2016 (actual)
- Study completion
- 1 Dec 2016 (actual)
- First posted
- 1 Dec 2021 (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.
After written consent from next-of-kin patients with severe traumatic brain injury was included from the neurointensive care unit (NICU) at Sahlgrenska university hospital, Gothenburg. Blood and CSF samples were collected during the initial 3 weeks after trauma. 1 year after trauma patients were assessed according to Glasgow outcome scale (GOS), NIHSS and Barthels. 10-15 years after trauma a repeated evaluation according to GOS was performed by telephone. Different biomarkers such as Neurofilament light, Glial fibrillary acidic protein and Tau among others, was analyzed from serum and CSF samples. Further patients were explored Apolipoprotein-E genetype (APOE). The investigators hypothesize that higher biomarkers concentrations and positive test for this gene relate to worse outcome 1-year and 10-15 years after trauma. Further that these biomarkers and genetic marker further have prognostic value on outcome 1-year and 10-15 years after trauma. Finally, the investigators want to explore the concentrations dynamics of these biomarkers in serum and CSF in the acute phase after trauma.
Detailed description
Patients with a severe traumatic brain injury (sTBI) were included after written consent from next-to kin. The injury was considered as severe if having a Glasgow coma scale of 8 or less. Within 48h of trauma patients were included from the neurointensive care unit at Sahlgrenska university hospital, Gothenburg during 2000-2004. Patients were intubated and had a ventricular catheter. All patients were treated in accordance with the Lund Concept. Samples from ventricular cerebrospinal fluid (CSF) and blood was collected, during the first 3 weeks, then prepared for storage and later analyzed. Samples were stored in -70 degrees Celsius until analyzed. 1 year after trauma patients were assessed according to Glasgow outcome scale (GOS), NIHSS and Barthels Index. 10-15 years after trauma an evaluation of GOS by phone was repeated. Biomarkers such as Neurofilament light, Glial fibrillary acidic protein, Tau among others is analyzed in serum and CSF. Further, patients APOE genotype was explored. The investigators hypothesizes that higher concentrations of these biomarkers both in serum and CSF relate to worse 1-year and 10-15 year outcome after a severe traumatic brain injury. Further, patients that have the gene APOE4 is predisposed to worse 1 year and 10-15 year outcome after a sTBI. The investigators further want to explore the dynamics of these biomarkers in serum and CSF in the acute phase after trauma and if these biomarkers gave any prognostic value to on outcome (mortality and functional) 1-year and 10-15 years after trauma.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 15 Years
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patient with severe traumatic brain injury, defined by our inclusion criteria, where enrolled from the Neurointensive care unit at Sahlgrenska university hospital, Gothenburg. Sahlgrenska University hospital is a tertiary hospital admitting patients from the whole south west part of Sweden.
Key inclusion criteria (3 listed)
- Reaction level scale >3, corresponding to a Glasgow coma scale <9
- A therapeutic indication for intracranial pressure monitoring
- Need for ventilator treatment
Key exclusion criteria (1 listed)
- Not residing in Sweden
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
In severe traumatic brain injury patient; Correlation of Neurochemical biomarkers analyzed in CSF and serum, assessed in the initial ICU period, correlated to Glasgow Outcome Scale (GOS) at 1 year post-trauma
Time frame: 1 year after trauma
GOS 1-3 - Poor outcome, GOS 4-5 Good outcome
In severe traumatic brain injury patient; Correlation of Neurochemical biomarkers analyzed in CSF and serum, assessed in the initial ICU period, correlated to Glasgow Outcome Scale (GOS) at 10-15 years post-trauma
Time frame: 10-15 years after trauma
GOS 1-3 - Poor outcome, GOS 4-5 Good outcome
In severe traumatic brain injury patient; correlation of the genetic alleles of APOE correlated to Glasgow Outcome Scale (GOS) at 1-year post-trauma)
Time frame: 1 year after trauma
GOS 1-3 - Poor outcome, GOS 4-5 Good outcome
In severe traumatic brain injury patient; correlation of the genetic alleles of APOE correlated to Glasgow Outcome Scale (GOS) at 10-15 years post-trauma)
Time frame: 10-15 years after trauma
GOS 1-3 - Poor outcome, GOS 4-5 Good outcome
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 1 Dec 2021.
- Derived from this study: PubMed 38769253Andersson E, Ost M, Dalla K, Zetterberg H, Blennow K, Nellgard B. Acute-Phase Neurofilament Light and Glial Fibrillary Acidic Proteins in Cerebrospinal Fluid Predict Long-Term Outcome After Severe Traumatic Brain Injury. Neurocrit Care. 2024 Dec;41(3):813-827. doi: 10.1007/s12028-024-01998-0. Epub 2024 May 20.
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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.
Bengt Nellgård, MD PhD Professor study director
University of Gothenburg and Västra götaland Regionen, Sahlgrenska Universitetssjukhus Mölndal
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 Traumatic Severe (Diagnosis) and Biomarkers, run by Bengt Nellgard at 1 site in Sweden.
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 3 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 1 Dec 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 Sweden. 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?
In severe traumatic brain injury patient; Correlation of Neurochemical biomarkers analyzed in CSF and serum, assessed in the initial ICU period, correlated to Glasgow Outcome Scale (GOS) at 1 year post-trauma (time frame: 1 year after trauma). 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 NCT05138692, which also lists 1 linked publication.
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 1 Dec 2021.