Subarachnoid Aneurysm Hemorrhage, Traumatic Brain Injury
Conditions
Keywords
Neuromonitoring
Brief summary
Neurocritical care has become a distinct discipline within the field of intensive care medicine with a major focus on the treatment of patients with acute damage to the most complex organ of the human body, the brain. The main indications for acute neurocritical care concern aneurysmal Subarachnoid Hemorrhage (SAH) and severe Traumatic Brain Injury (TBI). These disease entities form a major health and socioeconomic problem as they afflict young patients and the rate of death and disability is high. The pathology and treatment of these patients is heterogeneous and complex. Despite advances in basic neuroscience which have increased our understanding of processes in the injured brain, approaches to management are largely unfocused and adhere to the concept of a 'one pill for everybody' approach. Novel monitoring technology and new neuroimaging techniques now offer opportunities for advancing the care for these patients to a more individualized targeted management. In the period of 2010-2014, a prospective trial was conducted in the Antwerp University Hospital, including 50 patients with either SAH or TBI, who underwent extensive monitoring, known as Individualized targeted management in neurocritical care. In NEMO-RETRO, the investigators want to answer proposed and new research questions in retrospective analyses, using current insights and methodologies. Objectives: 1. Cerebral blood flow monitoring 1. Investigate the effect of changes in therapy (nature/intensity) on Cerebral Blood Flow (CBF) measured by thermal diffusion flowmetry and Transcranial Doppler (TCD) 2. Determine the added value of continuous CBF monitoring for the early detection of vasospasm and ischaemia 2. Brain tissue oxygen tension 1. Investigate the effect of changes in therapy (nature/intensity) on cerebral oxygenation as measured by Brain Tissue Oxygen Tension (PTiO2) 2. Investigate the relation between PTiO2 and hemodynamic parameters such as CBF, CPP, and ICP 3. Systemic effects of brain specific therapy 1. Investigate the effects of brain-targeted therapy on cardiac output and lung function 2. Determine the relation of CBF to cardiac output, in particular following triple H therapy 4. Neuroimaging 1. Accurately document structural brain damage following TBI and SAH 2. Document vasospasm and quantify flow and perfusion 3. Quantify the degree of secondary ischaemic damage to the brain 4. Differentiate swelling from edema 5. Train and validate models to interpret neuroimaging 5. Outcome 1. Assess global functional outcome at 6 months post-injury 2. Assess health-related quality of life at 6 months after injury 6. Integrated approach analysis 1. Describe the effects of brain-targeted therapy on cerebral and systemic parameters 2. Define the added value of extended multimodality monitoring and advanced neuroimaging to detect vasospasm and secondary ischaemic damage, defined by markers of neuronal injury and cell death 3. Develop recommendations for individualized targeted management
Interventions
Imaging: CT, MRI, XA Neuromonitoring: Brain Tissue Monitoring Probe, Hemedex, External ventricular drain, Cortical microdialysis catheter Other monitoring: Arterial catheter, Jugular bulb catheter, routine vital parameters
Sponsors
CENTER TBI
Research Foundation - Flanders (Fonds Wetenschappelijk Onderzoek)
University Hospital, Antwerp
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
This study is based on the 50 patients recruited for the original study. For TBI: Inclusion Criteria: * male or female patients aged 18 to 70 years, inclusive * sustained head injury within the previous 24 hours * TBI diagnosed by history, clinical examination with a GCS of 12 or less * evidence of TBI confirmed by abnormalities on CT scan * clinical indication to monitor ICP * informed consent is obtained from the patient or from a legally acceptable representative
Exclusion criteria
* life expectancy of less than 24 hours as determined by the investigator * any spinal cord injury * coma suspected to be primarily due to causes other than head injury, such as drug or alcohol overdose * clinically significant or active gastro-intestinal, renal, hepatic, endocrine or CNS disease or chronic condition (e.g.psychiatric disorder) that can be ascertained at the time of admission and could affect functional outcome * respiratory/hemodynamic instability, refractory to treatment and precluding transport for neuroimaging studies * pregnancy * special
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with a favourable neurological outcome | From enrollment to the end of follow-up at 6 months | Glasgow Outcome Scale - Extended (GOSE; 1 = Dead, 8 = Upper good recovery) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in abnormalities on neuroimaging through CT, MRI or XA | From enrollment to the end of the study at 6 months | Change based on evolution of bleeding areas, ischemic areas, edema |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in IL-1β | From enrollment up to 12 days, unless earlier ICU discharge | Measurement of interleukin-1 beta (pg/mL) |
| Change from baseline in IL-6 | From enrollment up to 12 days, unless earlier ICU discharge | Measurement of interleukin-6 (pg/mL) |
| Change from baseline in GFAP | From enrollment up to 12 days, unless earlier ICU discharge | Measurement of glial fibrillary acidic protein (ng/mL, plasma/CSF) |
| Change from baseline in S100B | From enrollment up to 12 days, unless earlier ICU discharge | Measurement of S100 calcium-binding protein B (ng/mL, plasma/CSF) |
| Change from baseline in NFL | From enrollment up to 12 days, unless earlier ICU discharge | Measurement of neurofilament light chain (ng/mL, plasma/CSF) |
| Change from baseline in UCH-L1 | From enrollment up to 12 days, unless earlier ICU discharge | Measurement of ubiquitin carboxy-terminal hydrolase L1 (ng/mL, plasma/CSF) |
| Change from baseline in MDA | From enrollment up to 12 days, unless earlier ICU discharge | Measurement of malondialdehyde (µmol/L) |
| Change from baseline in Ferritin | From enrollment up to 12 days, unless earlier ICU discharge | Measurement of ferritin (ng/mL) |
| Change from baseline in Hepcidin | From enrollment up to 12 days, unless earlier ICU discharge | Measurement of hepcidin (ng/mL) |
| Change from baseline in Syndecan | From enrollment up to 12 days, unless earlier ICU discharge | Measurement of syndecan (ng/mL) |
| Change from baseline in CHI3L1 | From enrollment up to 12 days, unless earlier ICU discharge | Measurement of chitinase-3-like protein 1 (ng/mL) |
| Change from baseline in TfR | From enrollment up to 12 days, unless earlier ICU discharge | Measurement of transferrin receptor (ng/mL) |
| Change from baseline in IL-1α | From enrollment up to 12 days, unless earlier ICU discharge | Measurement of interleukin-1 alpha (pg/mL) |
| Change from baseline in Fe²⁺ | From enrollment up to 12 days, unless earlier ICU discharge | Measurement of ferrous iron (µmol/L) |
| Change from baseline in IL-10 | From enrollment up to 12 days, unless earlier ICU discharge | Measurement of interleukin-10 (pg/mL) |
| Change from baseline in IL-18 | From enrollment up to 12 days, unless earlier ICU discharge | Measurement of interleukin-18 (pg/mL) |
| Change from baseline in IL-23 | From enrollment up to 12 days, unless earlier ICU discharge | Measurement of interleukin-23 (pg/mL) |
| Change from baseline in IL-1RA | From enrollment up to 12 days, unless earlier ICU discharge | Measurement of interleukin-1 receptor antagonist (pg/mL) |
| Change from baseline in TNFα | From enrollment up to 12 days, unless earlier ICU discharge | Measurement of tumor necrosis factor alpha (pg/mL) |
| Change from baseline in GDF-15 | From enrollment up to 12 days, unless earlier ICU discharge | Measurement of growth differentiation factor 15 (ng/mL) |
| Change from baseline in NSE | From enrollment up to 12 days, unless earlier ICU discharge | Measurement of neuron-specific enolase (ng/mL, plasma/CSF) |
Outcome results
None listed