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

Biomarkers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05138692
• Other study ID #: Neuromarkers and neurotrauma
• Status: Completed
• Start date: October 1, 2000
• Est. completion date: December 1, 2016

Study information

• Verified date: November 2021
• Source: Sahlgrenska University Hospital, Sweden
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: December 1, 2016
• Est. primary completion date: December 1, 2016
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Biomarkers
• Brain Injuries
• Brain Injuries, Traumatic
• Brain Injury Traumatic Severe (Diagnosis)
• Wounds and Injuries

Locations

Country	Name	City	State
Sweden	Sahlgrenska University Hospital	Molndal	Vastra Gotaland

Sponsors (3)

Lead Sponsor	Collaborator
Bengt Nellgard	Stroke Foundation, Svenska alzheimerfonden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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