Recruiting

Observational Study

Sponsor:

CHU de Quebec-Universite Laval

Code:

NCT04935866

Conditions

Traumatic Brain Injury

Subarachnoid Hemorrhage

Brain Injuries

Near-Infrared Spectroscopy

Intensive Care Neurological Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Near-infrared spectroscopy (NIRS)

Study Details

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

Conditions

Traumatic Brain Injury

Subarachnoid Hemorrhage

Brain Injuries

Near-Infrared Spectroscopy

Intensive Care Neurological Disorder

Study ID

NCT04935866

Start date

May 7, 2021

Status verified date

Aug, 2022

Completion date

Jul, 2025

Anticipated

Primary completion date

Jul, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

286 participants

Anticipated

Interventions and Outcome Measures

Interventions

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.

Primary outcome measure

  • Glasgow Outcome Scale extended [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Lucy Clayton, MSc

418-525-4444lucy.clayton.hsj@ssss.gouv.qc.ca

Angie Tuttle, MSc

613-737-8899antuttle@ohri.ca

Locations

The Ottawa Hospital

Recruiting

Ottawa, Ontario, Canada

CHU de Québec - Université Laval (Hôpital de l'Enfant-Jésus)

Recruiting

Québec City, Quebec, Canada, G1J-1Z4

Contacts

Alexis Turgeon, MD MSc

418-525-4444alexis.turgeon@crchudequebec.ulaval.ca

More Information

Sponsor

CHU de Quebec-Universite Laval

Last update posted

Aug 18, 2022

Last verified

Aug, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by CHU de Quebec-Universite Laval on 2022-08-18.