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

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

Study Overview

• Status: Recruiting
• Conditions: Brain Injuries; Anemia; Traumatic Brain Injury; Subarachnoid Hemorrhage; Intensive Care Neurological Disorder; Near-Infrared Spectroscopy
• Intervention / Treatment: Other: Near-infrared spectroscopy (NIRS)

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 Type: Observational
• Enrollment (Anticipated): 286

Contacts and Locations

• Study Contact: Name: Lucy Clayton, MSc; Phone Number: 64056 418-525-4444; Email: lucy.clayton.hsj@ssss.gouv.qc.ca
• Study Contact Backup: Name: Angie Tuttle, MSc; Phone Number: 75084 613-737-8899; Email: antuttle@ohri.ca

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada
      • Recruiting
      • The Ottawa Hospital
      • Contact: Shane W English, MD MSc
  • Quebec
    • Québec City, Quebec, Canada, G1J-1Z4
      • Recruiting
      • CHU de Québec - Université Laval (Hôpital de l'Enfant-Jésus)
      • Contact: Alexis Turgeon, MD MSc; Phone Number: 66056 418-525-4444; Email: alexis.turgeon@crchudequebec.ulaval.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: CHU de Quebec-Universite Laval
• Collaborators: Ottawa Hospital Research Institute; Canadian Critical Care Trials Group; Canadian Traumatic Brain Injury Research Consortium
• Investigators: Principal Investigator: Alexis F Turgeon, MD MSc FRCPC, CHU de Québec-Universite Laval Research Center, Universite Laval; Principal Investigator: Shane W English, MD MSc FRCPC, Ottawa Hospital Research Institute

Publications and helpful links

Helpful Links

• Canadian Traumatic Brain Injury Research Consortium
• Canada Research Chair in Critical Care Neurology and Trauma

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2021
• Primary Completion (Anticipated): July 1, 2024
• Study Completion (Anticipated): July 1, 2025

Study Registration Dates

• First Submitted: June 15, 2021
• First Submitted That Met QC Criteria: June 15, 2021
• First Posted (Actual): June 23, 2021

Study Record Updates

• Last Update Posted (Actual): August 18, 2022
• Last Update Submitted That Met QC Criteria: August 16, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Intracranial Hemorrhages; Brain Injuries; Wounds and Injuries; Hemorrhage; Brain Injuries, Traumatic; Nervous System Diseases; Subarachnoid Hemorrhage
• Other Study ID Numbers: MP-20-2021-5673

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: To be determined

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No