Impact of Acute Normovolemic Hemodilution on Whole Blood Coagulation Profile During Post-cardiopulmonary Bypass in Cardiac Surgery: Rotational Thromboelastometry Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Maximal clot firmness of EXTEM
研究概览
简要总结
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.
详细描述
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients undergoing cardiac surgery with cardiopulmonary bypass who signed written informed consent
排除标准
- •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
研究组 & 干预措施
Acute normovolemic hemodilution group
patients undergoing cardiac surgery supposed to get aucte normovolemic hemodilution (ANH) before CPB
干预措施: Acute normovolemic hemodilution (ANH) (Procedure)
Acute normovolemic hemodilution group
patients undergoing cardiac surgery supposed to get aucte normovolemic hemodilution (ANH) before CPB
干预措施: hydroxyethyl starch (HES 130/0.6) (Drug)
结局指标
主要结局
Maximal clot firmness of EXTEM
时间窗: 10 min after completion of acute normovolemic hemodilution (ANH)
Maxiaml clot firmess (MCF) of EXTEM of rotational thromboleastometry
次要结局
- A10 of FIBTEM(10 min after completion of acute normovolemic hemodilution)
- Clot formation time of EXTEM(10 min after completion of acute normovolemic hemodilution)
研究者
Tae-Yop Kim, MD PhD
Professor of Anesthesiology
Konkuk University Medical Center