Clinical trial NCT00566709: Near Infrared Spectroscopy (NIRS) as Transfusion Indicator in Neurocritical Patients
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Traumatic Brain Injury
Subarachnoid Hemorrhage
Intracerebral Hemorrhage
Keywords: transfusion
NIRS
cerebral oxygenation
red blood cell
near infrared spectroscopy
Lead sponsor: Hospitales Universitarios Virgen del Rocío
Sponsor class: OTHER
First posted: 2007-12-03
Enrollment: 102
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Number of Units of Packed Red Blood Cell Transfused
timeFrame: duration of the protocol, an average of 15 days
measure: Percentage of Transfused Patients in Each Group
timeFrame: duration of the protocol, an average of 15 days
Secondary outcomes:
measure: Hospital Mortality
timeFrame: length of the hospital stay, an average of 20 days
measure: Length of Intensive Care Unit (ICU) Stay
timeFrame: The length of ICU stay, an avarege of 17 days
measure: Long-term Mortality
timeFrame: 1-year after hospital discharge
measure: Unfavorable Glasgow Outcome Scale (GOS)
timeFrame: At hospital discharge, an average of 21 days
Other outcomes:
Locations:
city: Seville
country: Spain
facility: Hospital Universitario "Virgen del Rocío"
Study officials:
affiliation: Hospital Universitario "Virgen del Rocío", Seville, Spain
name: Santiago R Leal-Noval, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario "Virgen del Rocío", Seville, Spain
name: Victoria Arellano, MD, PhD
role: STUDY_CHAIR
affiliation: Hospital Universitario "Virgen del Rocío", Seville, Spain
name: Rosario Amaya, MD, PhD
role: STUDY_CHAIR
affiliation: Hospital Universitario "Virgen del Rocío", Seville, Spain
name: Antonio M Puppo, MD, PhD
role: STUDY_CHAIR
affiliation: Hospital Universitario "Virgen del Rocío", Seville, Spain
name: Carmen M Ferrándiz, MD
role: STUDY_CHAIR
affiliation: Hospital Universitario "Virgen del Rocío", Seville, Spain
name: Antonio J Marín, MD, PhD
role: STUDY_CHAIR
affiliation: Hospital Universitario "Virgen del Rocío", Seville, Spain
name: Francisco Murillo, MD, PhD
role: STUDY_DIRECTOR
affiliation: Prof Transfusion Medicine University of Malaga, Spain
name: Manuel Muñoz, Prof, MD, PhD
role: STUDY_CHAIR
affiliation: Hospitales Universitarios Virgen del Rocío
name: Vicente Padilla, MD
role: STUDY_CHAIR
affiliation: Hospitales Universitarios Virgen del Rocío
name: Yael Corcia, MD
role: STUDY_CHAIR
affiliation: Hospital Universitario Virgen del Rocio
name: Aurelio Cayuela, MD, PhD
role: STUDY_CHAIR
References:
citation: Leal-Noval SR, Arellano-Orden V, Munoz-Gomez M, Cayuela A, Marin-Caballos A, Rincon-Ferrari MD, Garcia-Alfaro C, Amaya-Villar R, Casado-Mendez M, Dusseck R, Murillo-Cabezas F. Red Blood Cell Transfusion Guided by Near Infrared Spectroscopy in Neurocritically Ill Patients with Moderate or Severe Anemia: A Randomized, Controlled Trial. J Neurotrauma. 2017 Sep;34(17):2553-2559. doi: 10.1089/neu.2016.4794. Epub 2017 Jul 19.