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

Anemia Clinical Trial

— NeurO2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04935866
• Other study ID #: MP-20-2021-5673
• Status: Recruiting
• Start date: May 7, 2021
• Est. completion date: July 2025

Study information

• Verified date: August 2022
• Source: CHU de Quebec-Universite Laval
• Contact: Lucy Clayton, MSc
• Phone: 418-525-4444
• Email: lucy.clayton.hsj[@]ssss.gouv.qc.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 286
• Est. completion date: July 2025
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Brain Injuries
• Brain Injuries, Traumatic
• Hemorrhage
• Intensive Care Neurological Disorder
• Near-Infrared Spectroscopy
• Nervous System Diseases
• Subarachnoid Hemorrhage
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
Canada	The Ottawa Hospital	Ottawa	Ontario
Canada	CHU de Québec - Université Laval (Hôpital de l'Enfant-Jésus)	Québec City	Quebec

Sponsors (4)

Lead Sponsor	Collaborator
CHU de Quebec-Universite Laval	Canadian Critical Care Trials Group, Canadian Traumatic Brain Injury Research Consortium, Ottawa Hospital Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Mortality	Incidence of mortality	6 months
Secondary	Hospital length of stay	Duration of hospital stay for the index hospitalisation	through study completion, an average of 6 months
Secondary	ICU length of stay	Duration of intensive care unit (ICU) stay for the index hospitalisation	through study completion, an average of 6 months
Secondary	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

External Links

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