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临床试验/NCT00566709
NCT00566709已完成2 期

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.

Hospitales Universitarios Virgen del Rocío2 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2009年6月1日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
102
试验地点
2
主要终点
Number of Units of Packed Red Blood Cell Transfused

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Number of Units of Packed Red Blood Cell Transfused

时间窗: duration of the protocol, an average of 15 days

Number of units of packed packed red blood cell transfused, over the period that the patient was included into the protocol

Percentage of Transfused Patients in Each Group

时间窗: duration of the protocol, an average of 15 days

次要结局

  • Hospital Mortality(length of the hospital stay, an average of 20 days)
  • Long-term Mortality(1-year after hospital discharge)
  • Length of Intensive Care Unit (ICU) Stay(The length of ICU stay, an avarege of 17 days)
  • Unfavorable Glasgow Outcome Scale (GOS)(At hospital discharge, an average of 21 days)

研究者

发起方
Hospitales Universitarios Virgen del Rocío
申办方类型
Other
责任方
Principal Investigator
主要研究者

Santiago R. Leal-Noval

Santiago R. Leal-Noval, MD Ph.D

Hospitales Universitarios Virgen del Rocío

研究点 (2)

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