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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2009-12-31

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.

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Detailed Description

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Conditions

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Traumatic Brain Injury Subarachnoid Hemorrhage Intracerebral Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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RBCT based on rSO2 value

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

Group Type EXPERIMENTAL

Red blood cells transfusion

Intervention Type PROCEDURE

Patients will be transfused (one to one red blood cells unit transfusion)

RBCT based on hemoglobin level value

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.

Group Type ACTIVE_COMPARATOR

Red blood cells transfusion

Intervention Type PROCEDURE

Patients will be transfused (one to one red blood cells unit transfusion)

Interventions

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Red blood cells transfusion

Patients will be transfused (one to one red blood cells unit transfusion)

Intervention Type PROCEDURE

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

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Santiago R. Leal-Noval

Santiago R. Leal-Noval, MD Ph.D

Responsibility Role PRINCIPAL_INVESTIGATOR