The Effect of 6% Hydroxyethyl Starch 130/0.4 on Blood Loss and Coagulation in Patients Medicated With Antiplatelet Agents Prior to Off-Pump Coronary Bypass Graft Surgery

Yonsei University2 个研究点分布在 2 个国家目标入组 106 人开始时间: 2009年5月最近更新: 2010年7月12日

适应症

试验速览

阶段: 4 期
状态: 已完成
发起方: Yonsei University
入组人数: 106
试验地点: 2
主要终点: TEG, hemoglobin, platelet count, prothrombin time (PT), partial prothrombin time (aPTT), blood loss, amount of transfusion, urine output, comparing the record data of IV fluid consumption

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

HES 130/0.4 significantly solution will not affect on coagulation and blood loss in patients medicated with antiplatelet agents prior to off-pump coronary bypass surgery (OPCAB).

研究设计

研究类型: Interventional
主要目的: Prevention

入排标准

年龄范围: 20 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Eighty patients undergoing OPCAB, who were exposed to anti platelet agents until 5 days prior to surgery were randomly allocated to infuse HES 130/0.4 up to 30 ml/kg and followed crystalloid infusion or infuse crystalloid only during perioperative period,

排除标准

•Patient who has
•Valvular disease of heart
•MI within 3 months,patient under 40% of left ventricle preoperative output
•left main artery stenosis
•anemia (hemoglobin < 12 g/dl), coagulopathy (Platelet < 100/nl, activated partial thromboplastin time, aPTT) > 80sec, serum creatinine > 1.2 mg/dl, respiratory disease(asthma, COPD, PaO2 < 70 mmHg, pulmonary hypertension or pulmonary edema, etc)
•not consented to this trial

结局指标

主要结局

TEG, hemoglobin, platelet count, prothrombin time (PT), partial prothrombin time (aPTT), blood loss, amount of transfusion, urine output, comparing the record data of IV fluid consumption

时间窗: Preoperative thromboelastography (TEG) and other coagulation variables were measured and follow up data were collected at immediate postoperatively and 24 hours after surgery.

次要结局

未报告次要终点

研究者

发起方

Yonsei University

申办方类型

Other

研究点 (2)

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