Multimodal Neuromonitoring at the ICU

NCT07285733 | Completed DMC

• 1 other identifier: EDGE 4584
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

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. 1.Cerebral blood flow monitoring
2. 2.Investigate the effect of changes in therapy (nature/intensity) on Cerebral Blood Flow (CBF) measured by thermal diffusion flowmetry and Transcranial Doppler (TCD)
3. 3.Determine the added value of continuous CBF monitoring for the early detection of vasospasm and ischaemia
4. 4.Brain tissue oxygen tension
5. 5.Investigate the effect of changes in therapy (nature/intensity) on cerebral oxygenation as measured by Brain Tissue Oxygen Tension (PTiO2)
6. 6.Investigate the relation between PTiO2 and hemodynamic parameters such as CBF, CPP, and ICP
7. 7.Systemic effects of brain specific therapy
8. 8.Investigate the effects of brain-targeted therapy on cardiac output and lung function
9. 9.Determine the relation of CBF to cardiac output, in particular following triple H therapy
10. 10.Neuroimaging
11. 11.Accurately document structural brain damage following TBI and SAH
12. 12.Document vasospasm and quantify flow and perfusion
13. 13.Quantify the degree of secondary ischaemic damage to the brain
14. 14.Differentiate swelling from edema
15. 15.Train and validate models to interpret neuroimaging
16. 16.Outcome
17. 17.Assess global functional outcome at 6 months post-injury
18. 18.Assess health-related quality of life at 6 months after injury
19. 19.Integrated approach analysis
20. 20.Describe the effects of brain-targeted therapy on cerebral and systemic parameters
21. 21.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
22. 22.Develop recommendations for individualized targeted management

Conditions

Subarachnoid Aneurysm Hemorrhage; Traumatic Brain Injury

Keywords

Neuromonitoring

Outcome Measures

Primary Outcomes (1)

• Number of participants with a favourable neurological outcome

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

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

Secondary Outcomes (1)

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

  From enrollment to the end of the study at 6 months

Other Outcomes (21)

• Change from baseline in NSE

  From enrollment up to 12 days, unless earlier ICU discharge

• Change from baseline in GFAP

  From enrollment up to 12 days, unless earlier ICU discharge

• Change from baseline in S100B

  From enrollment up to 12 days, unless earlier ICU discharge

Study Arms (1)

Acute brain injury

Patients with acute brain injury (TBI or aSAH)

Device: Multimodal neuromonitoring

Interventions

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

Acute brain injury

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primarily admitted to the Antwerp University Hospital

You may qualify if:

• 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

You may not qualify if:

• 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
• informed consent is obtained from a legally acceptable representative, prior to any study related activity
• For aneurysmal subarachnoid hemorrhage:
• 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
• non-aneurysmal subarachnoid hemorrhage

Sponsors & Collaborators

• University Hospital, Antwerp: lead
• CENTER TBI: collaborator
• Research Foundation - Flanders (Fonds Wetenschappelijk Onderzoek): collaborator

Biospecimen

Retention: SAMPLES WITHOUT DNA

Cerebrospinal fluid and plasma were retained in the original prospective study. No additional biospecimens will be included in this retrospective study.

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: December 16, 2025
• Study Start: February 1, 2010
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: December 16, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 3 months and ending 1 year after publication of results.
• Access Criteria: Researchers may request data by contacting the original investigators. An official application must be submitted to the original investigators, who will determine whether data sharing is approved. In the event of approval, a formal data-sharing agreement will be established between the requesting researchers and the original investigators. All data sharing will be conducted in accordance with the local regulations of Antwerp University Hospital.