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Biomarkers and Outcome 1 and 10-15 Years After Severe Traumatic Brain Injury

The Association Between Initial Concentrations of Biomarkers and Outcome 1 and 10-15 Years After Severe Traumatic Brain Injury

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05138692
Enrollment
99
Registered
2021-12-01
Start date
2000-10-01
Completion date
2016-12-01
Last updated
2021-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biomarkers, Brain Injury Traumatic Severe (Diagnosis)

Brief 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. 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.

Interventions

None listed

Sponsors

Svenska alzheimerfonden
CollaboratorUNKNOWN
Stroke Foundation
CollaboratorUNKNOWN
Bengt Nellgard
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL

Inclusion criteria

* Reaction level scale \>3, corresponding to a Glasgow coma scale \<9 * A therapeutic indication for intracranial pressure monitoring * Need for ventilator treatment

Exclusion criteria

* Not residing in Sweden

Design outcomes

Primary

MeasureTime frameDescription
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-trauma1 year after traumaGOS 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-trauma10-15 years after traumaGOS 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)1 year after traumaGOS 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)10-15 years after traumaGOS 1-3 - Poor outcome, GOS 4-5 Good outcome

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026