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NCT Number: NCT00566709

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

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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Key information

Conditions

Traumatic Brain Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Cardiovascular Diseases Central Nervous System Diseases Cerebral Hemorrhage Cerebrovascular Disorders Craniocerebral Trauma Hemorrhage Intracerebral Hemorrhage Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Subarachnoid Hemorrhage Trauma, Nervous System Vascular Diseases Wounds and Injuries

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hospital Universitario "Virgen del Rocío"

Seville, 41013, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Red blood cells transfusion

Procedure

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

Primary outcomes

  1. Number of Units of Packed Red Blood Cell Transfused

    Time frame: duration of the protocol, an average of 15 days

    Number of units of packed packed red blood cell transfused, over the period that the patient was included into the protocol

  2. Percentage of Transfused Patients in Each Group

    Time frame: duration of the protocol, an average of 15 days

Secondary outcomes

  1. Hospital Mortality

    Time frame: length of the hospital stay, an average of 20 days

  2. Length of Intensive Care Unit (ICU) Stay

    Time frame: The length of ICU stay, an avarege of 17 days

  3. Long-term Mortality

    Time frame: 1-year after hospital discharge

  4. Unfavorable Glasgow Outcome Scale (GOS)

    Time frame: At hospital discharge, an average of 21 days

    GOS measures the degree of disability associated with the brain injury

    Unfavorable GOS included the categories of:

    • death.
    • vegetative status.
    • severe disability.

Sponsors and collaborators

Lead sponsor

Hospitales Universitarios Virgen del Rocío

Other

Registry information

Official study 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.

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Dec 3, 2007
Registry last updated
Apr 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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