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Sponsored by: |
Hospitales Universitarios Virgen del Rocío |
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Information provided by: | Hospitales Universitarios Virgen del Rocío |
ClinicalTrials.gov Identifier: | NCT00566709 |
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 |
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Traumatic Brain Injury Subarachnoid Hemorrhage Intracerebral Hemorrhage |
Procedure: Red blood cells transfusion |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
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. |
Estimated Enrollment: | 80 |
Study Start Date: | December 2007 |
Estimated Study Completion Date: | December 2009 |
Arms | Assigned Interventions |
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1: Experimental
In the rSO2 - strategy group, patients will be transfused to attain a post-transfusion rSO2 values higher than 60%.
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Procedure: Red blood cells transfusion
Patients will be transfused (one to one red blood cells unit transfusion)
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2: Active Comparator
In the hemoglobin - strategy group, patients will be transfused to reach post-transfusion hemoglobin levels between 8.5 g/dL and 10 g/dL.
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Procedure: Red blood cells transfusion
Patients will be transfused (one to one red blood cells unit transfusion)
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Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 | |
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 |
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 | Hospital Universitario "Virgen del Rocío" |
Study Chair: | Yael Corcia, MD | Hospital Universitario "Virgen del Rocío" |
Study Chair: | Aurelio Cayuela, MD, PhD | Hospital Universitario "Virgen del Rocio" |
Responsible Party: | Hospitales Universitarios "Virgen del Rocío" ( Leal-Noval, Santiago R. ) |
Study ID Numbers: | PI-0157/2006, PI 157/06 |
Study First Received: | November 29, 2007 |
Last Updated: | September 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00566709 |
Health Authority: | Spain: Ethics Committee |
transfusion NIRS cerebral oxygenation |
Craniocerebral Trauma Cerebral Hemorrhage Vascular Diseases Wounds and Injuries Central Nervous System Diseases Disorders of Environmental Origin Intracranial Hemorrhages |
Trauma, Nervous System Hemorrhage Brain Diseases Cerebrovascular Disorders Subarachnoid Hemorrhage Brain Injuries |
Pathologic Processes Nervous System Diseases Cardiovascular Diseases |