Markers of primary and secondary traumatic axonal injury: predictive value for acute and long-term outcome

Markers of primary and secondary traumatic axonal injury: predictive value for acute and long-term outcome - Markers of primary and secondary traumatic axonal injury

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON30829

Enrollment

100

Registered

2007-09-07

Start date

2007-07-01

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

traumatologische aandoeningen Brain injury caused by trauma Traumatic Brain Injury

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Patients who visit the emergency department with a moderate or severe TBI 2. Initial trauma occurred less than 24 hours before visiting the Emergency Department. 3. Age >= 18 years and

Exclusion criteria

Exclusion criteria: Penetrating injury to the skull No written informed consent by patient or proxy History of severe neurological disease Chronic alcohol or drug abuse for MRI: Metal implants other than teeth fillings Claustrophobia

Design outcomes

Primary

Measure	Time frame
Project A Blood and (if possible) CSF/micro dialysis perfusate will be collected four times a day during ICU/MCU admission to analyze the presence of primary and secondary biochemical injury markers. A CT/MRI made within 72 hours after injury will be used to assess primary focal or axonal damage. ICU registration such as hypoxia, hypotension and increased ICP are used as indications for secondary damage. The GOSE serves as the primary outcome measure. Project B A MRI-scan using T1, FLAIR, T2*, SWI and DTI will be performed within 3 weeks and 6 months post-injury to assess diffuse axonal lesions and focal damage. An extensive follow-up including cognitive, motor and neurological assessments at 4 weeks, 3,6 and 12 months post injury, is aimed at measuring the degree of recovery. Furthermore, a broad neuropsychological evaluation and a structural interview will be performed to evaluate behavioral/cognitive outcome at 6 months after injury. Project C For the genetics study, a blood sample will be collected at the Emergency Department. The GOSE will be used as outcome measure.	—

Measure

Time frame

Project A Blood and (if possible) CSF/micro dialysis perfusate will be collected four times a day during ICU/MCU admission to analyze the presence of primary and secondary biochemical injury markers. A CT/MRI made within 72 hours after injury will be used to assess primary focal or axonal damage. ICU registration such as hypoxia, hypotension and increased ICP are used as indications for secondary damage. The GOSE serves as the primary outcome measure. Project B A MRI-scan using T1, FLAIR, T2*, SWI and DTI will be performed within 3 weeks and 6 months post-injury to assess diffuse axonal lesions and focal damage. An extensive follow-up including cognitive, motor and neurological assessments at 4 weeks, 3,6 and 12 months post injury, is aimed at measuring the degree of recovery. Furthermore, a broad neuropsychological evaluation and a structural interview will be performed to evaluate behavioral/cognitive outcome at 6 months after injury. Project C For the genetics study, a blood sample will be collected at the Emergency Department. The GOSE will be used as outcome measure.

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Countries

Netherlands

Outcome results