Near Infrared Spectroscopy (NIRS) as Transfusion Indicator in Neurocritical Patients

Study Overview
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Brief Summary
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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.

Official Title
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Phase II Study of Usefulness of Near Infrared Spectroscopy to Optimize Red Blood Cells Transfusion in Neuro Critical Ill Patients With Severe Traumatic Brain Injury, Subarachnoid Hemorrhage or Intracerebral Hemorrhage.

Conditions
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Traumatic Brain Injury, Subarachnoid Hemorrhage, Intracerebral Hemorrhage

Intervention / Treatment
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* Procedure: Red blood cells transfusion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RBCT based on rSO2 value<br>Intervention: In the rSO2 - strategy group, patients will be transfused to attain a post-transfusion rSO2 values higher than 60%. | Procedure: Red blood cells transfusion<br>* Patients will be transfused (one to one red blood cells unit transfusion)<br>|
| Active Comparator: RBCT based on hemoglobin level value<br>Intervention: In the hemoglobin - strategy group, patients will be transfused to reach post-transfusion hemoglobin levels between 8.5 g/dL and 10 g/dL. | Procedure: Red blood cells transfusion<br>* Patients will be transfused (one to one red blood cells unit transfusion)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Units of Packed Red Blood Cell Transfused | Number of units of packed packed red blood cell transfused, over the period that the patient was included into the protocol | duration of the protocol, an average of 15 days | 
| Percentage of Transfused Patients in Each Group |  | duration of the protocol, an average of 15 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital Mortality |  | length of the hospital stay, an average of 20 days | 
| Length of Intensive Care Unit (ICU) Stay |  | The length of ICU stay, an avarege of 17 days | 
| Long-term Mortality |  | 1-year after hospital discharge | 
| Unfavorable Glasgow Outcome Scale (GOS) | GOS measures the degree of disability associated with the brain injury Unfavorable GOS included the categories of: death. vegetative status. severe disability. | At hospital discharge, an average of 21 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transfusion, NIRS, cerebral oxygenation, red blood cell, near infrared spectroscopy