Traumatic Brain InjuryNEMO-RETRONCT07285733
Multimodal Neuromonitoring at the ICU
An observational study of Traumatic Brain Injury and Subarachnoid Aneurysm Hemorrhage, run by University Hospital, Antwerp.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Traumatic Brain Injury, Subarachnoid Aneurysm Hemorrhage
- What is being tested?
- Multimodal neuromonitoring
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Feb 2010to Apr 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primarily admitted to the Antwerp University Hospital
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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:
- 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
About this study
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".
Read more
In NEMO-RETRO, the investigators want to answer proposed and new research questions in retrospective analyses, using current insights and methodologies.
Objectives:
- Cerebral blood flow monitoring
- Investigate the effect of changes in therapy (nature/intensity) on Cerebral Blood Flow (CBF) measured by thermal diffusion flowmetry and Transcranial Doppler (TCD)
- Determine the added value of continuous CBF monitoring for the early detection of vasospasm and ischaemia
- Brain tissue oxygen tension
- Investigate the effect of changes in therapy (nature/intensity) on cerebral oxygenation as measured by Brain Tissue Oxygen Tension (PTiO2)
- Investigate the relation between PTiO2 and hemodynamic parameters such as CBF, CPP, and ICP
- Systemic effects of brain specific therapy
- Investigate the effects of brain-targeted therapy on cardiac output and lung function
- Determine the relation of CBF to cardiac output, in particular following triple H therapy
- Neuroimaging
- Accurately document structural brain damage following TBI and SAH
- Document vasospasm and quantify flow and perfusion
- Quantify the degree of secondary ischaemic damage to the brain
- Differentiate swelling from edema
- Train and validate models to interpret neuroimaging
- Outcome
- Assess global functional outcome at 6 months post-injury
- Assess health-related quality of life at 6 months after injury
- Integrated approach analysis
- Describe the effects of brain-targeted therapy on cerebral and systemic parameters
- 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
- Develop recommendations for individualized targeted management
- Being tested
- Multimodal neuromonitoring
- Keywords
- Neuromonitoring
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal neuromonitoringDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Acute brain injury | Patients with acute brain injury (TBI or aSAH) Receives: Device: Multimodal neuromonitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with a favourable neurological outcome
Glasgow Outcome Scale - Extended (GOSE; 1 = Dead, 8 = Upper good recovery)
Measured: 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
Change based on evolution of bleeding areas, ischemic areas, edema
Measured: From enrollment to the end of the study at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study startFeb 2010
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Collaborators
- CENTER TBI, Research Foundation - Flanders (Fonds Wetenschappelijk Onderzoek)
- Responsible party
- Principal investigator, Philppe Jorens, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07285733
- Sponsor's protocol ID
- EDGE 4584
- Acronym
- NEMO-RETRO
- Status last verified
- Nov 2025
- First submitted
- 19 Nov 2025
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) will be shared in accordance with the defined research questions. All data will be anonymized prior to analysis, and transfer procedures will be carried out in full compliance with hospital regulations.
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Neuromonitoring at the ICU
- ClinicalTrials.gov ID
- NCT07285733
- Acronym / sponsor ID
- NEMO-RETRO / EDGE 4584
- Keywords
- Neuromonitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Collaborators
- CENTER TBI, Research Foundation - Flanders (Fonds Wetenschappelijk Onderzoek)
- Study start
- Feb 2010 (actual)
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 16 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Cerebral blood flow monitoring
- Investigate the effect of changes in therapy (nature/intensity) on Cerebral Blood Flow (CBF) measured by thermal diffusion flowmetry and Transcranial Doppler (TCD)
- Determine the added value of continuous CBF monitoring for the early detection of vasospasm and ischaemia
- Brain tissue oxygen tension
- Investigate the effect of changes in therapy (nature/intensity) on cerebral oxygenation as measured by Brain Tissue Oxygen Tension (PTiO2)
- Investigate the relation between PTiO2 and hemodynamic parameters such as CBF, CPP, and ICP
- Systemic effects of brain specific therapy
- Investigate the effects of brain-targeted therapy on cardiac output and lung function
- Determine the relation of CBF to cardiac output, in particular following triple H therapy
- Neuroimaging
- Accurately document structural brain damage following TBI and SAH
- Document vasospasm and quantify flow and perfusion
- Quantify the degree of secondary ischaemic damage to the brain
- Differentiate swelling from edema
- Train and validate models to interpret neuroimaging
- Outcome
- Assess global functional outcome at 6 months post-injury
- Assess health-related quality of life at 6 months after injury
- Integrated approach analysis
- Describe the effects of brain-targeted therapy on cerebral and systemic parameters
- 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
- Develop recommendations for individualized targeted management
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute brain injury | – | Device: Multimodal neuromonitoringPatients with acute brain injury (TBI or aSAH) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primarily admitted to the Antwerp University Hospital
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multimodal neuromonitoringImaging: 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 | Device | Acute brain injury |
Primary outcome
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)
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) will be shared in accordance with the defined research questions. All data will be anonymized prior to analysis, and transfer procedures will be carried out in full compliance with hospital regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury and Subarachnoid Aneurysm Hemorrhage, run by University Hospital, Antwerp.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with a favourable neurological outcome (time frame: From enrollment to the end of follow-up at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.