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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Santiago R. Leal-Noval, Hospitales Universitarios Virgen del Rocío
ClinicalTrials.gov Identifier:
NCT00566709
First received: November 29, 2007
Last updated: March 21, 2016
Last verified: March 2016

November 29, 2007
March 21, 2016
June 2009
November 2009   (final data collection date for primary outcome measure)
  • Number of Units of Packed Red Blood Cell Transfused [ Time Frame: duration of the protocol, an average of 15 days ] [ Designated as safety issue: No ]
    Number of units of packed packed red blood cell transfused, over the period that the patient was included into the protocol
  • Percentage of Transfused Patients in Each Group [ Time Frame: duration of the protocol, an average of 15 days ] [ Designated as safety issue: No ]
To compare the efficacy of two red blood cells transfusion (RBCT) indicators in decreasing RBCT in a neurocritical care patient population - Number of Red Blood Cell (RBC) transfused - Percentage of transfused patients in each group [ Time Frame: length of stay at intensive care unit ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00566709 on ClinicalTrials.gov Archive Site
  • Hospital Mortality [ Time Frame: length of the hospital stay, an average of 20 days ] [ Designated as safety issue: Yes ]
  • Length of Intensive Care Unit (ICU) Stay [ Time Frame: The length of ICU stay, an avarege of 17 days ] [ Designated as safety issue: Yes ]
  • Long-term Mortality [ Time Frame: 1-year after hospital discharge ] [ Designated as safety issue: Yes ]
  • Unfavorable Glasgow Outcome Scale (GOS) [ Time Frame: At hospital discharge, an average of 21 days ] [ Designated as safety issue: Yes ]

    GOS measures the degree of disability associated with the brain injury

    Unfavorable GOS included the categories of:

    1. death.
    2. vegetative status.
    3. severe disability.
Sixty days mortality Length of ICU Stay and Hospital Stay. [ Time Frame: hospital stay and 2 moths period after the hospital discharge ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Near Infrared Spectroscopy (NIRS) as Transfusion Indicator in Neurocritical Patients
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Traumatic Brain Injury
  • Subarachnoid Hemorrhage
  • Intracerebral Hemorrhage
Procedure: Red blood cells transfusion
Patients will be transfused (one to one red blood cells unit transfusion)
  • Experimental: 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%.
    Intervention: Procedure: Red blood cells transfusion
  • Active Comparator: 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.
    Intervention: Procedure: Red blood cells transfusion
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
102
December 2009
November 2009   (final data collection date for primary outcome measure)

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
Both
16 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00566709
PI-0157/2006, PI 157/06
Yes
Not Provided
Not Provided
Santiago R. Leal-Noval, Hospitales Universitarios Virgen del Rocío
Hospitales Universitarios Virgen del Rocío
Not Provided
Principal Investigator: Santiago R Leal-Noval, MD, PhD Hospital Universitario "Virgen del Rocío", Seville, Spain
Study Chair: Victoria Arellano, MD, PhD Hospital Universitario "Virgen del Rocío", Seville, Spain
Study Chair: Rosario Amaya, MD, PhD Hospital Universitario "Virgen del Rocío", Seville, Spain
Study Chair: Antonio M Puppo, MD, PhD Hospital Universitario "Virgen del Rocío", Seville, Spain
Study Chair: Carmen M Ferrándiz, MD Hospital Universitario "Virgen del Rocío", Seville, Spain
Study Chair: Antonio J Marín, MD, PhD Hospital Universitario "Virgen del Rocío", Seville, Spain
Study Director: Francisco Murillo, MD, PhD Hospital Universitario "Virgen del Rocío", Seville, Spain
Study Chair: Manuel Muñoz, Prof, MD, PhD Prof Transfusion Medicine University of Malaga, Spain
Study Chair: Vicente Padilla, MD Hospitales Universitarios Virgen del Rocío
Study Chair: Yael Corcia, MD Hospitales Universitarios Virgen del Rocío
Study Chair: Aurelio Cayuela, MD, PhD Hospital Universitario "Virgen del Rocio"
Hospitales Universitarios Virgen del Rocío
March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP