Traumatic Brain InjuryNeurO2NCT04935866
Optimal Brain Oxygenation in Neurologic Intensive Care Unit : The NeurO2 Study
An observational study of Traumatic Brain Injury and Subarachnoid Hemorrhage, run by CHU de Quebec-Universite Laval at 2 sites in Canada.
Trial summary
The NeurO2 study is a multicenter observational study looking at NIRS monitoring in neurocrocritically ill patients during the acute phase of care following an acute brain injury. The study is nested within the HEMOTION Trial and the SAHaRA Trial Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury, Subarachnoid Hemorrhage, Brain Injuries
- What is being tested?
- Near-infrared spectroscopy (NIRS)
- How many people
- 286 participants
- Where
- 2 sitesCanada
- Study dates
- 7 May 2021to Jul 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients hospitalized with a traumatic brain injury or with aneurysmal subarachnoid hemorrhage already enrolled in the HEMOTION Trial or the SAHaRA Trial
Who may be able to join
- Enrolment in one of the parent trials (HEMOTION or SAHaRA trials)
- HEMOTION trial (acute moderate of severe blunt traumatic brain injury (Glasgow Coma Score18 [GCS] ≤ 12))
- SAHaRA trial (acute subarachnoid hemorrhage as confirmed by treating neurosurgeon or neuro-interventionist and supported by blood in subarachnoid space resulting from a ruptured aneurysm)
- Adult patients (age ≥18 years old)
- Patients suffering from anemia (Hb ≤100 g/L)
Who cannot join
- Contraindications or known objections to blood transfusions
- Active bleeding with hemodynamic instability at the time of enrollment
- Decision to withdraw or withhold life-sustaining therapies made
- NIRS monitoring not reliable
Trial locations and contacts
2 sites in 1 country.
Canada2 sites, 2 recruiting
- Recruiting
The Ottawa Hospital
Ottawa, Ontario
Shane W English, MD MSc
- Recruiting
CHU de Québec - Université Laval (Hôpital de l'Enfant-Jésus)
Québec, Quebec, G1J-1Z4
Alexis Turgeon, MD MSc, 418-525-4444 ext. 66056, alexis.turgeon@crchudequebec.ulaval.ca
About this study
The NeurO2 study is a multicenter observational study looking at NIRS monitoring in neurocrocritically ill patients during the acute phase of care following an acute brain injury. The study is nested within the HEMOTION Trial and the SAHaRA Trial
Read the detailed description
The NeurO2 study is a multicenter prospective study nested within two large-scale pragmatic randomized open blinded endpoint (PROBE) trials in neurocritically ill patients, the HEMOTION and the SAHaRa trials. These two trials are designed to compare a restrictive and a liberal transfusion strategies in critically ill patients with traumatic brain injury or subarachnoid hemorrhage. The NeurO2 will report on prospectively gathered regional cerebral oxygenation data (rSO2) from enrolled patients randomized to either the liberal or restrictive RBC transfusion strategy of their parent trials. The primary outcome will be 6-month neurologic function based on the GOSe. The established infrastructure of the trials will be used, including part of the data collection instruments and the outcome assessment team.
The NeurO2 study will achieve three separate but interconnected primary objectives: i) Evaluate if the cerebral hypoxemic burden as measured by NIRS during NICU stay, is associated with functional neurologic outcome (Glasgow Outcome Scale extended - GOSe) at 6 months, ii) Determine if the cerebral hypoxemic burden is impacted by red blood cell transfusion, iii) Determine if the level of response in cerebral hypoxemic burden after RBC transfusion is associated with the 6-month functional neurologic outcome (GOSe)
The secondary objectives are to evaluate whether the cerebral hypoxemic burden measured by NIRS is associated with other clinically relevant outcomes including ICU, hospital and 6-month mortality and hospital, ICU length of stay and quality of life.
- Conditions
- Traumatic Brain Injury, Subarachnoid Hemorrhage, Brain Injuries, Near-Infrared Spectroscopy, Intensive Care Neurological Disorder, Anemia
- Being tested
- Near-infrared spectroscopy (NIRS)
- Medical subject headings
- Brain Injuries, Traumatic, Subarachnoid Hemorrhage, Brain Injuries, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Near-infrared spectroscopy (NIRS)Other
Non invasive brain oxygenation monitoring with Near-Infrared Spectroscopy (NIRS) technology. Patients enrolled in the NeurO2 study will have bilateral NIRS sensors applied to the forehead according to manufacturer recommendations. Data will be monitored continuously throughout the study intervention in the parent trials (HEMOTION and SAHaRA trials) in the neurocritical care unit. Data will be extracted from the device at the end of the study period.
What is being measured
The primary outcome is the main question the study is designed to answer.
Glasgow Outcome Scale extended
The GOSe is an ordinal scale on 8 points evaluating the neurological functional outcome in neurocritically ill patients where 1 represents death and 8 the best possible outcome.
Measured: 6 months
Secondary outcomes (4)
Mortality
Incidence of mortality
Measured: 6 months
Hospital length of stay
Duration of hospital stay for the index hospitalisation
Measured: through study completion, an average of 6 months
ICU length of stay
Duration of intensive care unit (ICU) stay for the index hospitalisation
Measured: through study completion, an average of 6 months
EQ-5D-5L
EQ-5D-5L is a standardised measure of health-related quality of life developed by the EuroQol Group. The EQ-5D-5L includes a 5-dimension questionnaire and an overall health question using a visual analogue scale (VAS). The 5 dimensions of the EQ-5D-5L are mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension is evaluated based on 5 levels (from the worst (1) to the best (5)). The overall health evaluation is based on a 100 point VAS where 100 means the optimal health
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2021
- Study start7 May 2021
- Primary completionJul 2024 (estimated)
- Study completionJul 2025 (estimated)
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
- Prospective
- Enrolment
- 286 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHU de Quebec-Universite Laval
- Sponsor type
- University, hospital or other
- Collaborators
- Ottawa Hospital Research Institute, Canadian Critical Care Trials Group, Canadian Traumatic Brain Injury Research Consortium
- Responsible party
- Principal investigator, Dr Alexis Turgeon, CHU de Quebec-Universite Laval
- Investigators
- Alexis F Turgeon, MD MSc FRCPC, Principal investigator, CHU de Québec-Universite Laval Research Center, Universite LavalShane W English, MD MSc FRCPC, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04935866
- Sponsor's protocol ID
- MP-20-2021-5673
- Acronym
- NeurO2
- Status last verified
- Aug 2022
- First submitted
- 15 Jun 2021
- Last updated
- 18 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: To be determined
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Brain Oxygenation in Neurologic Intensive Care Unit : The NeurO2 Study
- ClinicalTrials.gov ID
- NCT04935866
- Acronym / sponsor ID
- NeurO2 / MP-20-2021-5673
- Conditions
- Traumatic Brain Injury, Subarachnoid Hemorrhage, Brain Injuries, Near-Infrared Spectroscopy, Intensive Care Neurological Disorder, Anemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 286 participants (estimated)
- Lead sponsor
- CHU de Quebec-Universite LavalUniversity, hospital or other
- Collaborators
- Ottawa Hospital Research Institute, Canadian Critical Care Trials Group, Canadian Traumatic Brain Injury Research Consortium
- Study start
- 7 May 2021 (actual)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 23 Jun 2021 (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.
The NeurO2 study is a multicenter observational study looking at NIRS monitoring in neurocrocritically ill patients during the acute phase of care following an acute brain injury. The study is nested within the HEMOTION Trial and the SAHaRA Trial
Detailed description
The NeurO2 study is a multicenter prospective study nested within two large-scale pragmatic randomized open blinded endpoint (PROBE) trials in neurocritically ill patients, the HEMOTION and the SAHaRa trials. These two trials are designed to compare a restrictive and a liberal transfusion strategies in critically ill patients with traumatic brain injury or subarachnoid hemorrhage. The NeurO2 will report on prospectively gathered regional cerebral oxygenation data (rSO2) from enrolled patients randomized to either the liberal or restrictive RBC transfusion strategy of their parent trials. The primary outcome will be 6-month neurologic function based on the GOSe. The established infrastructure of the trials will be used, including part of the data collection instruments and the outcome assessment team.
The NeurO2 study will achieve three separate but interconnected primary objectives: i) Evaluate if the cerebral hypoxemic burden as measured by NIRS during NICU stay, is associated with functional neurologic outcome (Glasgow Outcome Scale extended - GOSe) at 6 months, ii) Determine if the cerebral hypoxemic burden is impacted by red blood cell transfusion, iii) Determine if the level of response in cerebral hypoxemic burden after RBC transfusion is associated with the 6-month functional neurologic outcome (GOSe)
The secondary objectives are to evaluate whether the cerebral hypoxemic burden measured by NIRS is associated with other clinically relevant outcomes including ICU, hospital and 6-month mortality and hospital, ICU length of stay and quality of life.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients hospitalized with a traumatic brain injury or with aneurysmal subarachnoid hemorrhage already enrolled in the HEMOTION Trial or the SAHaRA Trial
Key inclusion criteria (5 listed)
- Enrolment in one of the parent trials (HEMOTION or SAHaRA trials)
- HEMOTION trial (acute moderate of severe blunt traumatic brain injury (Glasgow Coma Score18 [GCS] ≤ 12))
- SAHaRA trial (acute subarachnoid hemorrhage as confirmed by treating neurosurgeon or neuro-interventionist and supported by blood in subarachnoid space resulting from a ruptured aneurysm)
- Adult patients (age ≥18 years old)
- Patients suffering from anemia (Hb ≤100 g/L)
Key exclusion criteria (4 listed)
- Contraindications or known objections to blood transfusions
- Active bleeding with hemodynamic instability at the time of enrollment
- Decision to withdraw or withhold life-sustaining therapies made
- NIRS monitoring not reliable
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 |
|---|---|---|
| Near-infrared spectroscopy (NIRS)Non invasive brain oxygenation monitoring with Near-Infrared Spectroscopy (NIRS) technology. Patients enrolled in the NeurO2 study will have bilateral NIRS sensors applied to the forehead according to manufacturer recommendations. Data will be monitored continuously throughout the study intervention in the parent trials (HEMOTION and SAHaRA trials) in the neurocritical care unit. Data will be extracted from the device at the end of the study period. | Other | – |
Primary outcome
Glasgow Outcome Scale extended
Time frame: 6 months
The GOSe is an ordinal scale on 8 points evaluating the neurological functional outcome in neurocritically ill patients where 1 represents death and 8 the best possible outcome.
4 secondary outcomes
Mortality
Time frame: 6 months
Hospital length of stay
Time frame: through study completion, an average of 6 months
ICU length of stay
Time frame: through study completion, an average of 6 months
EQ-5D-5L
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2022.
- Canadian Traumatic Brain Injury Research ConsortiumLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. To be determined
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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.
Alexis F Turgeon, MD MSc FRCPC principal investigator
CHU de Québec-Universite Laval Research Center, Universite Laval
Shane W English, MD MSc FRCPC principal investigator
Ottawa Hospital Research Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury and Subarachnoid Hemorrhage, run by CHU de Quebec-Universite Laval at 2 sites in Canada.
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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 18 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lucy Clayton, MSc (418-525-4444 ext. 64056, lucy.clayton.hsj@ssss.gouv.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glasgow Outcome Scale extended (time frame: 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 18 Aug 2022.