NCT04935866

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 286 (estimated)
• Sponsor: CHU de Quebec-Universite Laval · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-05-07
• Primary completion: 2024-07-01
• Completion: 2025-07-01
• First posted: 2021-06-23
• Last updated: 2022-08-18

Locations

2 sites across 1 country: Canada