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
  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:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 80
Study Start Date: December 2007
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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: 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.
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
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

Contacts
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

Locations
Spain
Hospital Universitario "Virgen del Rocío" Recruiting
Seville, Spain, 41013
Contact: Santiago R Leal-Noval, MD, PhD    0-34-55012528 ext 312528    sramon@cica.es   
Contact: Victoria Arellano, MD, PhD    0-34-5012528 ext 312528    victoria_are_or@hotmail.com   
Principal Investigator: Santiago R Leal-Noval, MD, PhD         
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

No publications provided

Responsible Party: Leal-Noval, Santiago R., 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
Last Updated: February 5, 2009
Health Authority: Spain: Ethics Committee

Keywords provided by Hospitales Universitarios Virgen del Rocío:
transfusion
NIRS
cerebral oxygenation

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 September 18, 2014