Role of genetic polymorphisms, inflammation and biomarkers in primary and secondary traumatic brain injury

Role of genetic polymorphisms, inflammation and biomarkers in primary and secondary traumatic brain injury - Markers of traumatic brain injury and outcome

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON31166

Enrollment

100

Registered

2007-11-15

Start date

2007-10-01

Completion date

Unknown

Last updated

2024-05-13

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

Conditions

Trauma braintrauma Traumatic brain injury

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Age >= 18 Severe TBI (GCS at first presentation 24 hours

Exclusion criteria

Exclusion criteria: Pregnancy No informed consent

Design outcomes

Primary

Measure	Time frame
Main study endpoints are genetic factors, clinical, biochemical and inflammatory markers. All parameters will be correlated to - determinants of primary injury (GCS at presentation, CT-findings) - determinants of secondary injury (hemodynamic, clinical and neurological parameters after admission to ICU) - MRI findings at 3 weeks and 6 months - Outcome (as determined by the extended Glasgow Outcome Score at 6 and 12 months post injury) - Neuropsychological testing at 3 weeks, 6 and 12 months post injury - Parasympathetic activity (measured using heart rate variability)	—

Measure

Time frame

Main study endpoints are genetic factors, clinical, biochemical and inflammatory markers. All parameters will be correlated to - determinants of primary injury (GCS at presentation, CT-findings) - determinants of secondary injury (hemodynamic, clinical and neurological parameters after admission to ICU) - MRI findings at 3 weeks and 6 months - Outcome (as determined by the extended Glasgow Outcome Score at 6 and 12 months post injury) - Neuropsychological testing at 3 weeks, 6 and 12 months post injury - Parasympathetic activity (measured using heart rate variability)

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Secondary

Measure	Time frame
Secondary objective of this study is to gain more insight in the pathophysiological mechanisms underlying the primary impact and subsequent ongoing cascade of events associated with secondary brain injury and development of edema. Special attention will be given to biochemical markers of brain injury and to inflammatory and vasogenic proteins and the possible modulating role of increased vagal activity in these patients.	—

Measure

Time frame

Secondary objective of this study is to gain more insight in the pathophysiological mechanisms underlying the primary impact and subsequent ongoing cascade of events associated with secondary brain injury and development of edema. Special attention will be given to biochemical markers of brain injury and to inflammatory and vasogenic proteins and the possible modulating role of increased vagal activity in these patients.

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Countries

Netherlands

Outcome results