Monitoring brain oxygen levels in critically ill patients with brain injuries
Optimal Brain Oxygenation in Neurologic Intensive Care Unit : The NeurO2 Study
This study is testing how monitoring oxygen levels in the brain can help understand the effects of blood transfusions on recovery in critically ill patients with brain injuries.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 286 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | CHU de Quebec-Universite Laval Academic / other |
| Locations | 2 sites (Ottawa, Ontario and 1 other locations) |
| Trial ID | NCT04935866 on ClinicalTrials.gov |
What this trial studies
The NeurO2 study is a multicenter observational study that focuses on monitoring regional cerebral oxygenation in neurocritically ill patients during the acute phase following brain injuries. It is nested within two larger trials, HEMOTION and SAHaRa, which compare different red blood cell transfusion strategies in patients with traumatic brain injury or subarachnoid hemorrhage. The study aims to evaluate the relationship between cerebral hypoxemia, red blood cell transfusion, and long-term neurological outcomes. Data will be collected on patients' oxygen levels and their functional recovery over a six-month period.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with moderate to severe traumatic brain injury or acute subarachnoid hemorrhage who are enrolled in the HEMOTION or SAHaRa trials.
Not a fit: Patients with contraindications to blood transfusions or those experiencing active bleeding and hemodynamic instability may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve understanding of how brain oxygenation affects recovery in patients with severe brain injuries.
How similar studies have performed: Other studies have shown promise in using near-infrared spectroscopy for monitoring brain oxygenation, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Ottawa, Ontario and 1 other locations
- The Ottawa Hospital — Ottawa, Ontario, Canada (Recruiting)
- CHU de Québec - Université Laval (Hôpital de l'Enfant-Jésus) — Québec City, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Alexis F Turgeon, MD MSc FRCPC — CHU de Québec-Universite Laval Research Center, Universite Laval
- Study coordinator: Lucy Clayton, MSc
- Email: lucy.clayton.hsj@ssss.gouv.qc.ca
- Phone: 418-525-4444
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.