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Phase 2 N=102 Randomized Treatment

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

Traumatic Brain Injury · Subarachnoid Hemorrhage · Intracerebral Hemorrhage

Enrolled (actual)
102
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcome: Primary: Number of Units of Packed Red Blood Cell Transfused — 0.9; 1.5 units — p=0.03

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Red blood cells transfusion (Procedure)
Age
Pediatric, Adult, Older Adult · 16+ yrs
Sex
All
Sponsor
Hospitales Universitarios Virgen del Rocío
Primary completion
Nov 2009

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Units of Packed Red Blood Cell Transfused
0.9; 1.5 0.03 sig
PRIMARY
Percentage of Transfused Patients in Each Group
54.3; 70.5 0.07
SECONDARY
Hospital Mortality
3; 5 0.56
SECONDARY
Length of Intensive Care Unit (ICU) Stay
21.00; 20.41 0.79
SECONDARY
Long-term Mortality
12; 12 0.77
SECONDARY
Unfavorable Glasgow Outcome Scale (GOS)
27; 36 0.22

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 7 g/dL and 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00566709). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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