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

Sponsor
CHU de Quebec-Universite Laval (Other)
Overall Status
Recruiting
CT.gov ID
NCT04935866
Collaborator
Ottawa Hospital Research Institute (Other), Canadian Critical Care Trials Group (Other), Canadian Traumatic Brain Injury Research Consortium (Other)
286
2
49.8
143
2.9

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Other: Near-infrared spectroscopy (NIRS)

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 Design

Study Type:
Observational
Anticipated Enrollment :
286 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Optimal Brain Oxygenation in Neurologic Intensive Care Unit : The NeurO2 Study
Actual Study Start Date :
May 7, 2021
Anticipated Primary Completion Date :
Jul 1, 2024
Anticipated Study Completion Date :
Jul 1, 2025

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Mortality [6 months]

    Incidence of mortality

  2. Hospital length of stay [through study completion, an average of 6 months]

    Duration of hospital stay for the index hospitalisation

  3. ICU length of stay [through study completion, an average of 6 months]

    Duration of intensive care unit (ICU) stay for the index hospitalisation

  4. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Ottawa Hospital Ottawa Ontario Canada
2 CHU de Québec - Université Laval (Hôpital de l'Enfant-Jésus) Québec City Quebec Canada G1J-1Z4

Sponsors and Collaborators

  • CHU de Quebec-Universite Laval
  • Ottawa Hospital Research Institute
  • Canadian Critical Care Trials Group
  • Canadian Traumatic Brain Injury Research Consortium

Investigators

  • Principal Investigator: Alexis F Turgeon, MD MSc FRCPC, CHU de Québec-Universite Laval Research Center, Universite Laval
  • Principal Investigator: Shane W English, MD MSc FRCPC, Ottawa Hospital Research Institute

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Dr Alexis Turgeon, Professor, CHU de Quebec-Universite Laval
ClinicalTrials.gov Identifier:
NCT04935866
Other Study ID Numbers:
  • MP-20-2021-5673
First Posted:
Jun 23, 2021
Last Update Posted:
Aug 18, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 18, 2022