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

Recruiting

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

• Registration Number: NCT04935866
• Lead Sponsor: CHU de Quebec-Universite Laval

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.

Study Timeline

• Study Start: 2021-05-07
• Study First Submitted: 2021-06-15
• Study First Submitted QC: 2021-06-15
• Study First Posted: 2021-06-23
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-16
• Last Update Posted: 2022-08-18
• Primary Completion: 2024-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 286

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Glasgow Outcome Scale extended	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.

Secondary Outcome Measures

Name	Time	Method
EQ-5D-5L	6 months	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
Mortality	6 months	Incidence of mortality
ICU length of stay	through study completion, an average of 6 months	Duration of intensive care unit (ICU) stay for the index hospitalisation
Hospital length of stay	through study completion, an average of 6 months	Duration of hospital stay for the index hospitalisation

Trial Locations

Locations (2)

CHU de Québec - Université Laval (Hôpital de l'Enfant-Jésus); 🇨🇦 Québec City, Quebec, Canada

The Ottawa Hospital; 🇨🇦 Ottawa, Ontario, Canada