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

NCT05138692 | Completed

• 1 other identifier: Neuromarkers and neurotrauma
• Study Type: observational
• Target: 99
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Injury Traumatic Severe (Diagnosis); Biomarkers

Outcome Measures

Primary Outcomes (4)

• 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

  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

  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

  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

  10-15 years after trauma

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

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

You may not qualify if:

• Not residing in Sweden

Sponsors & Collaborators

• Bengt Nellgard: lead
• Svenska alzheimerfonden: collaborator
• Stroke Foundation: collaborator

Study Sites (1)

Sahlgrenska University Hospital

Mölndal, Västra Götaland County, 431 80, Sweden

Location

Biospecimen

Retention: SAMPLES WITH DNA

Biomarkers Neurofilament light (NFL) and Glial Fibrillary Acid Protein (GFAP) were analyzed in CSF, TAU in serum, APOE- genotype was explored in whole blood

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bengt Nellgård, MD PhD Professor

  University of Gothenburg and Västra götaland Regionen, Sahlgrenska Universitetssjukhus Mölndal

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 15 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: November 18, 2021
• First Posted: December 1, 2021
• Study Start: October 1, 2000
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: December 1, 2021

Record last verified: 2021-11

Locations

SE (1)