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临床试验/NCT01906515
NCT01906515已完成不适用

Continuous and Noninvasive Hemoglobin Monitoring Reduces Red Blood Cell Transfusion During Neurosurgery: A Prospective Cohort Study

Cairo University0 个研究点目标入组 106 人开始时间: 2012年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
106
主要终点
The Effect of SpHb on Transfusion Timeline

研究概览

简要总结

Continuous and noninvasive hemoglobin (SpHb) monitoring provides clinicians with real-time trending of changes or lack of changes in hemoglobin, which has the potential to alter red blood cell (RBC) transfusion decision making. The objective of this study was to evaluate the impact of SpHb monitoring on RBC transfusions in high blood loss surgery. The investigators hypothesize that SpHb will improve blood transfusion practice in the for of change the number of blood unit per patient and improve the outcome regards the time to take decision of transfusion trigger.

详细描述

Eligible patients scheduled for neurosurgeries were enrolled into either a standard care group (Control Group) or an intervention group (SpHb Group). The Control Group received typical anesthesia care including estimated blood loss (EBL) assessment and intraoperative hemoglobin measurements from the central laboratory (Hb). Blood samples were taken when EBL was ≥15% of total blood volume. RBC transfusion was initiated if Hb was ≤10 g/dL and continued until the EBL was replaced and Hb >10g/dL was confirmed. The SpHb Group followed the same transfusion practice as the Control Group except the anesthesiologist was guided by the addition of SpHb monitoring with blood samples still taken pre- and post-transfusion. Additionally, the absolute and trend accuracy of SpHb compared to Hb was evaluated. Potential cost savings from reduced RBC utilization will be calculated if occured.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
15 Years 至 60 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • ASA 1,2 patients from 15 to 60 years old scheduled for neurosurgical procedure

排除标准

  • Exclusion criteria included significant liver or renal disease, coagulopathy, pregnancy, anemia, and patients scheduled for procedures with excepted low blood loss.

结局指标

主要结局

The Effect of SpHb on Transfusion Timeline

时间窗: During surgery (an average of about 4 hours)

Length of time it takes to initiate a RBC transfusion after the need was first established.

RBC Transfusions Per Subject Receiving a Transfusion

时间窗: During surgery (an average of about 4 hours)

Determine whether using SpHb can affect the quantity of RBC transfused, per patient receiving a transfusion.

次要结局

  • SpHb Absolute and Trend Accuracy(During surgery (an average of about 4 hours))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

wael awada

Assistant Lecturer Cairo University

Cairo University

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