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
  Purpose

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.


Condition Intervention Phase
Traumatic Brain Injury
Subarachnoid Hemorrhage
Intracerebral Hemorrhage
Procedure: Red blood cells transfusion
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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.

Resource links provided by NLM:


Further study details as provided by Hospitales Universitarios Virgen del Rocío:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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.


Enrollment: 102
Study Start Date: June 2009
Study Completion Date: December 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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%.
Procedure: Red blood cells transfusion
Patients will be transfused (one to one red blood cells unit 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.
Procedure: Red blood cells transfusion
Patients will be transfused (one to one red blood cells unit transfusion)

  Eligibility

Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00566709

Locations
Spain
Hospital Universitario "Virgen del Rocío"
Seville, Spain, 41013
Sponsors and Collaborators
Hospitales Universitarios Virgen del Rocío
Investigators
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"
  More Information

Responsible Party: Santiago R. Leal-Noval, Santiago R. Leal-Noval, MD Ph.D, Hospitales Universitarios Virgen del Rocío
ClinicalTrials.gov Identifier: NCT00566709     History of Changes
Other Study ID Numbers: PI-0157/2006  PI 157/06 
Study First Received: November 29, 2007
Results First Received: November 20, 2015
Last Updated: March 21, 2016
Health Authority: Spain: Ethics Committee

Keywords provided by Hospitales Universitarios Virgen del Rocío:
transfusion
NIRS
cerebral oxygenation
red blood cell
near infrared spectroscopy

Additional relevant MeSH terms:
Brain Injuries
Hemorrhage
Subarachnoid Hemorrhage
Cerebral Hemorrhage
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 26, 2016