Near Infrared Spectroscopy (NIRS) as Transfusion Indicator in Neurocritical Patients
Condition: Traumatic Brain Injury; Subarachnoid Hemorrhage; Intracerebral Hemorrhage
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Subarachnoid Hemorrhage; Cerebral Hemorrhage; Hemorrhage
Intervention: Red blood cells transfusion
Intervention description: Patients will be transfused (one to one red blood cells unit transfusion)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 102.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No
Keywords: transfusion; NIRS; cerebral oxygenation; red blood cell; near infrared spectroscopy

Summary:

      Neurocritical ill patients are frequently transfused. Red blood cell transfusion (RBCT) in
      these patients has been associated with deleterious effects, including higher rates of
      nosocomial infections, multi-organ failure, and mortality. Therefore, it seems crucial to
      avoid any unnecessary RBCT.

      Most critically ill patients tolerate hemoglobin levels near 7 g/dL without an increase in
      morbidity or mortality rates. In this regard, a recent sub-analysis of TRICC trial has showed
      that TBI patients may tolerate hemoglobin levels as low as 7 g/dL, but other studies
      including neurocritical patients suggested that severe anemia may worsen clinical outcome.
      Therefore, optimal hemoglobin levels in neurocritical care patients remain largely unknown.
      Some textbooks and guidelines recommend to transfuse these patients to reach hemoglobin
      levels near to 10 g/dL, despite the lack of a solid scientific background supporting this
      target.

      Even though it has not been demonstrated, hemoglobin-based RBCT prescription could result in
      over- or under-transfusion in neurocritical patients. Alternatively, it has been suggested
      that more physiological transfusion triggers, using direct signals coming from the brain,
      will progressively replace arbitrary hemoglobin-based transfusion triggers in the
      neurocritical patients [65]. At the neurocritical units, patients are often monitored by
      using non-invasive methods, such as near infrared spectroscopy which indirectly measures
      regional cerebral oxygen saturation (rSO2). Changes in rSO2 values have been shown to
      directly correlate with changes in erythrocyte mass, thus increasing with RBCT and decreasing
      with blood losses. Moreover, rSO2 values also show a good correlation with clinical outcome
      and other variables which are often monitored in TBI patients.

      The purpose of this study is to ascertain as to whether rSO2 levels are more efficacious than
      conventional hemoglobin levels in guiding RBCT in patients admitted to a neurocritical care
      unit.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Severe traumatic brain injury (Glasgow coma scale < 9), subarachnoid hemorrhage (Hunt
             and Hess scale ≥ 3) or intracranial hemorrhage

          -  Moderate anemia. Hemoglobin levels > 7 g/dL and < 10 g/dL

          -  Hemodynamical stability (mean arterial pressure > 75 mm Hg)

          -  Respiratory stability (PaO2 / FiO2 ratio > 220)

          -  Expected length of ICU stay > 3 days

        Exclusion Criteria:

          -  Patient's relatives' refusal to patient's inclusion in the study

          -  Active bleeding

          -  Ongoing need for blood products

          -  Patients necessitating ongoing resuscitation

          -  End-stage in which death is imminent

          -  Antecedents of angina or myocardial infarction (poor cardiopulmonary reserve)

          -  Deficient signal of rSO2 impeding its proper valuation