Traumatic Brain Injury Clinical Trial
Official title:
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.
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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