Optimal Brain Oxygenation in Neurologic Intensive Care Unit : The NeurO2 Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Optimal Brain Oxygenation in Neurologic Intensive Care Unit : The NeurO2 Study

Conditions
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Anemia, Traumatic Brain Injury, Subarachnoid Hemorrhage, Brain Injuries, Near-Infrared Spectroscopy, Intensive Care Neurological Disorder

Intervention / Treatment
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* Other: Near-infrared spectroscopy (NIRS)


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: 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) Exclusion criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: 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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Incidence of mortality | 6 months | 
| Hospital length of stay | Duration of hospital stay for the index hospitalisation | through study completion, an average of 6 months | 
| ICU length of stay | Duration of intensive care unit (ICU) stay for the index hospitalisation | 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 | 6 months |