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Completed

NCT Number: NCT07285733

Multimodal Neuromonitoring at the ICU

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

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Key information

Conditions

Traumatic Brain Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Subarachnoid Aneurysm Hemorrhage Trauma, Nervous System Wounds and Injuries

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 exclusion criteria for MRI, such as non-removable metals, artificial joints, electronic devices (pacemaker, pumps etc.)
  • informed consent is obtained from a legally acceptable representative, prior to any study related activity

For aneurysmal subarachnoid hemorrhage:

Inclusion criteria

  • male or female patients aged 18 to 70 years, inclusive
  • ruptured aneurysm, demonstrated by CT angiography or DSA
  • onset of SAH clinical symptoms within the preceding 72 hours
  • World Federation of Neurosurgery (WFNS) grade III-IV and grade V patients, who improve within 24 hours after ventriculostomy
  • indication for ICP monitoring or CSF drainage
  • informed consent is obtained from the patient or a legally acceptable representative

Exclusion criteria

  • non-aneurysmal subarachnoid hemorrhage
  • admission in a clinical state with extremely poor prognosis (e.g. wide, non-reactive pupils for more than 1 hour)
  • significant coagulation disturbances (thrombocytes < 80 per mL, partial thromboplastin time > 45 sec, INR > 1.5)
  • cytostatic therapy in patients with malignant disease
  • pregnancy
  • special exclusion criteria for MRI, such as non-removable metals, artificial joints, electronic devices (pacemaker, pumps etc.)
  • respiratory and/or hemodynamic instability precluding

Treatment and study plan

Multimodal neuromonitoring

Device

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

Primary outcomes

  1. Number of participants with a favourable neurological outcome

    Time frame: From enrollment to the end of follow-up at 6 months

    Glasgow Outcome Scale - Extended (GOSE; 1 = Dead, 8 = Upper good recovery)

Secondary outcomes

  1. Change from baseline in abnormalities on neuroimaging through CT, MRI or XA

    Time frame: From enrollment to the end of the study at 6 months

    Change based on evolution of bleeding areas, ischemic areas, edema

Other outcomes

  1. Change from baseline in NSE

    Time frame: From enrollment up to 12 days, unless earlier ICU discharge

    Measurement of neuron-specific enolase (ng/mL, plasma/CSF)

  2. Change from baseline in GFAP

    Time frame: From enrollment up to 12 days, unless earlier ICU discharge

    Measurement of glial fibrillary acidic protein (ng/mL, plasma/CSF)

  3. Change from baseline in S100B

    Time frame: From enrollment up to 12 days, unless earlier ICU discharge

    Measurement of S100 calcium-binding protein B (ng/mL, plasma/CSF)

  4. Change from baseline in NFL

    Time frame: From enrollment up to 12 days, unless earlier ICU discharge

    Measurement of neurofilament light chain (ng/mL, plasma/CSF)

  5. Change from baseline in UCH-L1

    Time frame: From enrollment up to 12 days, unless earlier ICU discharge

    Measurement of ubiquitin carboxy-terminal hydrolase L1 (ng/mL, plasma/CSF)

  6. Change from baseline in MDA

    Time frame: From enrollment up to 12 days, unless earlier ICU discharge

    Measurement of malondialdehyde (µmol/L)

  7. Change from baseline in Ferritin

    Time frame: From enrollment up to 12 days, unless earlier ICU discharge

    Measurement of ferritin (ng/mL)

  8. Change from baseline in Hepcidin

    Time frame: From enrollment up to 12 days, unless earlier ICU discharge

    Measurement of hepcidin (ng/mL)

  9. Change from baseline in GDF-15

    Time frame: From enrollment up to 12 days, unless earlier ICU discharge

    Measurement of growth differentiation factor 15 (ng/mL)

  10. Change from baseline in CHI3L1

    Time frame: From enrollment up to 12 days, unless earlier ICU discharge

    Measurement of chitinase-3-like protein 1 (ng/mL)

  11. Change from baseline in TfR

    Time frame: From enrollment up to 12 days, unless earlier ICU discharge

    Measurement of transferrin receptor (ng/mL)

  12. Change from baseline in IL-1α

    Time frame: From enrollment up to 12 days, unless earlier ICU discharge

    Measurement of interleukin-1 alpha (pg/mL)

  13. Change from baseline in Fe²⁺

    Time frame: From enrollment up to 12 days, unless earlier ICU discharge

    Measurement of ferrous iron (µmol/L)

  14. Change from baseline in Syndecan

    Time frame: From enrollment up to 12 days, unless earlier ICU discharge

    Measurement of syndecan (ng/mL)

  15. Change from baseline in IL-1β

    Time frame: From enrollment up to 12 days, unless earlier ICU discharge

    Measurement of interleukin-1 beta (pg/mL)

  16. Change from baseline in IL-6

    Time frame: From enrollment up to 12 days, unless earlier ICU discharge

    Measurement of interleukin-6 (pg/mL)

  17. Change from baseline in IL-10

    Time frame: From enrollment up to 12 days, unless earlier ICU discharge

    Measurement of interleukin-10 (pg/mL)

  18. Change from baseline in IL-18

    Time frame: From enrollment up to 12 days, unless earlier ICU discharge

    Measurement of interleukin-18 (pg/mL)

  19. Change from baseline in IL-23

    Time frame: From enrollment up to 12 days, unless earlier ICU discharge

    Measurement of interleukin-23 (pg/mL)

  20. Change from baseline in IL-1RA

    Time frame: From enrollment up to 12 days, unless earlier ICU discharge

    Measurement of interleukin-1 receptor antagonist (pg/mL)

  21. Change from baseline in TNFα

    Time frame: From enrollment up to 12 days, unless earlier ICU discharge

    Measurement of tumor necrosis factor alpha (pg/mL)

Sponsors and collaborators

Lead sponsor

University Hospital, Antwerp

Other

Collaborators

  • CENTER TBI
  • Research Foundation - Flanders (Fonds Wetenschappelijk Onderzoek)

Registry information

Acronym: NEMO-RETRO

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Dec 16, 2025
Registry last updated
Dec 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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