Please select the arm or intervention descriptions that belong to the clinical trial below.
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.
Brief 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.


Options:
A: Arm Label: Restrictive Transfusion Policy; Type: ACTIVE_COMPARATOR; Interventions: Other: Restrictive transfusion policy | Arm Label: Liberal Transfusion Policy; Type: ACTIVE_COMPARATOR; Interventions: Other: Liberal Transfusion Policy | Intervention Type: OTHER; Name: Restrictive transfusion policy; Assigned to Arm(s): Restrictive Transfusion Policy | Intervention Type: OTHER; Name: Liberal Transfusion Policy; Assigned to Arm(s): Liberal Transfusion Policy
B: Arm Label: RBCT based on rSO2 value; Type: EXPERIMENTAL; Interventions: Procedure: Red blood cells transfusion | Arm Label: RBCT based on hemoglobin level value; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Red blood cells transfusion | Intervention Type: PROCEDURE; Name: Red blood cells transfusion; Assigned to Arm(s): RBCT based on hemoglobin level value, RBCT based on rSO2 value
C: Arm Label: Restrictive transfusion strategy; Type: EXPERIMENTAL; Interventions: Procedure: Restrictive transfusion, Biological: red blood transfusion | Arm Label: Liberal transfusion strategy; Type: EXPERIMENTAL; Interventions: Procedure: Liberal transfusion, Biological: red blood transfusion | Intervention Type: PROCEDURE; Name: Restrictive transfusion; Assigned to Arm(s): Restrictive transfusion strategy | Intervention Type: PROCEDURE; Name: Liberal transfusion; Assigned to Arm(s): Liberal transfusion strategy | Intervention Type: BIOLOGICAL; Name: red blood transfusion; Assigned to Arm(s): Liberal transfusion strategy, Restrictive transfusion strategy
D: Arm Label: "liberal" transfusion triggers; Type: EXPERIMENTAL; Interventions: Other: red blood cell transfusion | Arm Label: "restrictive" transfusion triggers; Type: ACTIVE_COMPARATOR; Interventions: Other: red blood cell transfusion | Intervention Type: OTHER; Name: red blood cell transfusion; Assigned to Arm(s): "liberal" transfusion triggers | Intervention Type: OTHER; Name: red blood cell transfusion; Assigned to Arm(s): "restrictive" transfusion triggers

Answer: B