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临床试验/NCT00518544
NCT00518544Unknown不适用

Hemostatic Effect of Various Colloid Solutions According to Blood Types

Samsung Medical Center2 个研究点 分布在 2 个国家开始时间: 2007年7月最近更新:
适应症
相关药物

试验速览

阶段
不适用
试验地点
2
主要终点
Blood loss, coagulation and metabolic profiles

研究概览

简要总结

Background: Individuals with type O blood have reduced factor VIII and von Willebrand factor levels compared to the non-O counterpart. Infusion of hydroxyethyl starch (HES) impairs coagulation and, in O blood type, apparent coagulopathy can develop after HES infusion. A newly market-released balanced HES (670/0.75) has physiologic pH and balanced electrolytes including calcium, which are beneficial to coagulation. Studies comparing balanced HES (670/0.75) with saline-based HES (130/0.4), previously known the least coagulopathic are rare. Therefore, we try to reveal the difference of coagulation, pH/electrolyte balance, and bleeding amount between the non-O and O blood types after infusion of these two newest HES.

Methods: Each 20 of non-O and type O ASA 1 or 2 patients scheduled for spinal surgery involving 2 or 3 spinal levels were enrolled. 20 ml/kg of saline-based HES (130/0.4) or balanced HES (670/0.75) was administered during operation. Blood loss, coagulation and metabolic profiles were checked at pre-infusion (T0), 5 min after infusion (T1), 4 hrs after infusion (T2) and 24 hrs after infusion (T4).

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
Double

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients of ASA 1 or 2, and scheduled for posterior laminectomy and internal fixation at two or three spinal levels.

排除标准

  • the presence of cardiovascular diseases, cerebral vascular disease, hepatic, pulmonary, or renal disease, hemoglobin < 12 g/dl, platelet count < 150,000 /ml, coagulopathy, taking medication likely to alter coagulation less than 2 weeks before the study, or an allergic reaction to HES

结局指标

主要结局

Blood loss, coagulation and metabolic profiles

时间窗: pre-infusion, 5 min after infusion, 4 hrs after infusion

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (2)

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