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.

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Key information

Conditions

Brain Injury Traumatic Severe (Diagnosis) Biomarkers Disease Pathologic Processes Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

Primary location

Sahlgrenska University Hospital

Mölndal, Västra Götaland County, 431 80, Sweden

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Bengt Nellgard

Other

Collaborators

Stroke Foundation
Svenska alzheimerfonden

Registry information

Official study title

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

Important dates

Study start: 2000
Primary completion: 2016
Study completion: 2016
First posted: Dec 1, 2021
Registry last updated: Dec 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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