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

Hospitales Universitarios Virgen del Rocío

Status and phase: Completed; Phase 2

Conditions: Subarachnoid Hemorrhage; Traumatic Brain Injury; Intracerebral Hemorrhage

Treatments: Procedure: Red blood cells transfusion

Study type: Interventional

Funder types: Other

Identifiers

NCT00566709

PI 157/06

PI-0157/2006

Details and patient eligibility

About

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.

Enrollment: 102 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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102 participants in 2 patient groups

RBCT based on rSO2 value

Experimental group

Description:

Intervention: In the rSO2 - strategy group, patients will be transfused to attain a post-transfusion rSO2 values higher than 60%.

Treatment:

Procedure: Red blood cells transfusion

RBCT based on hemoglobin level value

Active Comparator group

Description:

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.

Treatment:

Procedure: Red blood cells transfusion