Acute Normovolemic Hemodilution on ROTEM in Cardiac Surgery
Impact of Acute Normovolemic Hemodilution on Whole Blood Coagulation Profile During Post-cardiopulmonary Bypass in Cardiac Surgery: Rotational Thromboelastometry Study
Impact of acute normovolemic hemodilution (ANH) using hydroxyethyl starch before initiating cardiopulmonary bypass (CPB) on whole blood viscoelastic profile after CPB has not been well established.
Patients undergoing cardiac surgery employing moderate hypothermic CPB (n=40) are randomly allocated into one of two groups: in Group-ANH(n=20), ANH is applied by using a balanced hydroxyethyl starch (HES 130/0.6); and in Group-C, ANH is not applied.
After weaning from CPB, intergroup differences of INTEM, EXTEM, FIBTEM and APTEM profiles are analyzed.
As a primary outcome, inter-group difference between maxiaml clot firmness of EXTEM will be determined at 10 min after ANH in Group-ANH and that at control.
研究概览
详细说明
Background: Impact of acute normovolemic hemodilution (ANH) using hydroxyethyl starch before initiating cardiopulmonary bypass (CPB) on whole blood viscoelastic profile after CPB has not been well established.
Method: Patients undergoing cardiac surgery employing moderate hypothermic CPB (n=40) are randomly allocated into one of two groups: in Group-ANH(n=20), ANH is applied by using a balanced hydroxyethyl starch (HES 130/0.6); and in Group-C ANH is not applied.
Intergroup differences of INTEM, EXTEM, FIBTEM and APTEM profiles are analyzed. after anesthesia induction (control) and after weaning form CPB and protamine neutralization (after-CPB) in both groups. In Group-ANH, those are determined after ANH (after-ANH).
As a primary outcome, inter-group difference between maxiaml clot firmness of EXTEM is determined at 10 min after ANH in Group-ANH and that at control.
As secondary outcomes, intergroup differences of Hematocrit (Hct), Na+, K+, HCO3-, Ca2+, osmolarity, s-Cr are determined Intergroup difference of data at T2 are performed.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Seoul、大韩民国、143-729
- Konkuk University Medical Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- patients undergoing cardiac surgery with cardiopulmonary bypass who signed written informed consent
Exclusion Criteria:
- preoperative renal failure requiring reran replacement therapy
- preoperative liver disease
- preoperative low cardiac output (EF < 50%)
- Preoperative IABP application, Atrial fibrillation, Pacemaker,
- contraindication for applying TEE
- intraoperative withdrawal
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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无干预：Control group
patients undergoing cardiac surgery supposed not to get aucte normovolemic hemodilution (ANH) before CPB
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有源比较器：Acute normovolemic hemodilution group
patients undergoing cardiac surgery supposed to get aucte normovolemic hemodilution (ANH) before CPB
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applying acute normovolemic hemodilution (ANH) by using HES 130/0.4 of 5 ml/kg before the initiation of cardiopulmonary bypass
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Maximal clot firmness of EXTEM
大体时间：10 min after completion of acute normovolemic hemodilution (ANH)
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Maxiaml clot firmess (MCF) of EXTEM of rotational thromboleastometry
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10 min after completion of acute normovolemic hemodilution (ANH)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Clot formation time of EXTEM
大体时间：10 min after completion of acute normovolemic hemodilution
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Clot formation time of EXTEM of rotational thromboleastometry
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10 min after completion of acute normovolemic hemodilution
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A10 of FIBTEM
大体时间：10 min after completion of acute normovolemic hemodilution
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A10 of FIBTEM of rotational thromboelastometry
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10 min after completion of acute normovolemic hemodilution
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合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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羟乙基淀粉 (HES 130/0.6)的临床试验
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Chung-Ang University Hosptial, Chung-Ang University...未知