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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Hospitales Universitarios Virgen del Rocío.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hospitales Universitarios Virgen del Rocío
ClinicalTrials.gov Identifier:
NCT00566709
First received: November 29, 2007
Last updated: February 5, 2009
Last verified: February 2009

November 29, 2007
February 5, 2009
December 2007
November 2009   (final data collection date for primary outcome measure)
  • To compare the efficacy of two red blood cells transfusion (RBCT) indicators in decreasing RBCT in a neurocritical care patient population [ Time Frame: length of stay at intensive care unit ] [ Designated as safety issue: Yes ]
  • Number of Red Blood Cell (RBC) transfused [ Time Frame: length of stay at intensive care unit ] [ Designated as safety issue: Yes ]
  • Percentage of transfused patients in each group [ Time Frame: length of stay at intensive care unit ] [ Designated as safety issue: Yes ]
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
  • Sixty days mortality [ Time Frame: hospital stay and 2 months period after the hospital discharge ] [ Designated as safety issue: Yes ]
  • Length of intensive care unit (ICU) stay and hospital stay [ Time Frame: hospital stay and 2 months period after the hospital discharge ] [ Designated as safety issue: Yes ]
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: 1
    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: 2
    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.
 
Recruiting
80
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
No
Contact: Santiago R Leal-Noval, MD, PhD 03455012528 ext 312528 sramon@cica.es
Contact: Victoria Arellano, MD, PhD 03455012528 ext 312528 victoria_are_or@hotmail.com
Spain
 
NCT00566709
PI-0157/2006, PI 157/06
Yes
Leal-Noval, Santiago R., 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
February 2009

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