Clinical trial NCT04935866: Optimal Brain Oxygenation in Neurologic Intensive Care Unit : The NeurO2 Study
Official title: Optimal Brain Oxygenation in Neurologic Intensive Care Unit : The NeurO2 Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Traumatic Brain Injury
Subarachnoid Hemorrhage
Brain Injuries
Near-Infrared Spectroscopy
Intensive Care Neurological Disorder
Anemia
Lead sponsor: CHU de Quebec-Universite Laval
Sponsor class: OTHER
Collaborators: name: Ottawa Hospital Research Institute
name: Canadian Critical Care Trials Group
name: Canadian Traumatic Brain Injury Research Consortium
First posted: 2021-06-23
Enrollment: 286
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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

Brief 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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Glasgow Outcome Scale extended
timeFrame: 6 months
Secondary outcomes:
measure: Mortality
timeFrame: 6 months
measure: Hospital length of stay
timeFrame: through study completion, an average of 6 months
measure: ICU length of stay
timeFrame: through study completion, an average of 6 months
measure: EQ-5D-5L
timeFrame: 6 months
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
city: Québec City
country: Canada
facility: CHU de Québec - Université Laval (Hôpital de l'Enfant-Jésus)
state: Quebec
Study officials:
affiliation: CHU de Québec-Universite Laval Research Center, Universite Laval
name: Alexis F Turgeon, MD MSc FRCPC
role: PRINCIPAL_INVESTIGATOR
affiliation: Ottawa Hospital Research Institute
name: Shane W English, MD MSc FRCPC
role: PRINCIPAL_INVESTIGATOR
References: