NCT00967109已完成不适用
Establishment of Optimal Transfusion Threshold During Spine Surgery
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- The change in subcutaneous oxygen tension from incision.
研究概览
简要总结
The purpose of this study is to determine whether a higher threshold for transfusion with red blood cells improves the tissue oxygenation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older
- •Patients undergoing spine surgery
- •Be legally competent
- •Read and understand Danish
排除标准
- •Present malignant disease
- •Previously apoplexia cerebri
- •Known heart disease with functionality equivalent to NYHA II or CCS II or worse
结局指标
主要结局
The change in subcutaneous oxygen tension from incision.
时间窗: Every fifteen minutes throughout surgery
The primary endpoint is the change in subcutaneous oxygen tension from incision until the time most patients is still undergoing surgery. Subcutaneous oxygen tension is measured every fifteen minutes throughout surgery. The oxygen tension is measured with a polygraphic electrode (Clark's electrode).
次要结局
- Oxygenation of the brain(Every fifteen minutes throughout surgery)
- The concentration of lactate in plasma(Every half an hour throughout surgery)
- Variation in the ST-segment of the ECG(Every fifteen minutes throughout surgery)
- Muscular saturation of the deltoid muscle(Every fifteen minutes throughout surgery)
- The change in subcutaneous oxygen tension from incision.(Every fifteen minutes throughout surgery)
研究者
研究点 (2)
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