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

• Conditions: Trauma; braintrauma; Traumatic brain injury; 10021666

• Registration Number: NL-OMON31166
• Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

Age >= 18
Severe TBI (GCS at first presentation <= 8)
Expected survival > 24 hours

Exclusion Criteria

Pregnancy
No informed consent

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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