NCT00657384终止3 期
Tranexamic Acid Versus Placebo to Reduce Perioperative Bleeding After Major Hepatectomy : a Prospective Randomized Double-blinding Study
University Hospital, Strasbourg, France4 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2008年8月20日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 130
- 试验地点
- 4
- 主要终点
- The volume of compensated blood loss with the formula: [TBV x (initial hematocrit - final hematocrit ) + number of transfused RBC unit] with TBV=Total Blood Volume and RBC= red blood cell (1 RBC unit = 500 ml with hematocrit=30%).
研究概览
简要总结
Blood loss was reported as a prognostic risk factor of morbidity and overall survival after hepatic resection. The aim of this study prospective randomized was compare the efficacy of the administration of tranexamic acid versus placebo to reduce perioperative bleeding after major hepatectomy (> 3 hepatic segments).
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 (Participant, Investigator)
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
- •Signature of the consent form
- •Patients with hepatic lesion needing a major hepatectomy (≥ 3 hepatic segments)
排除标准
- •Absence of signature of the consent form
- •Patient with cirrhosis
- •Minor hepatectomy (< 3 hepatic segments)
- •Hepatectomy associated with vascular resection
- •Contraindication of tranexamic acid : history of arterial or venous thrombosis , disseminated intravascular coagulation, severe renal insufficiency, history of epilepsies , intrathecal or intraventricular injection
- •Pregnant or lactation
研究组 & 干预措施
2
Placebo Comparator
Nacl 0.9%
干预措施: Nacl 0.9% (Drug)
acid tranexamic
Experimental
acid tranexamic
干预措施: acid tranexamic (Drug)
结局指标
主要结局
The volume of compensated blood loss with the formula: [TBV x (initial hematocrit - final hematocrit ) + number of transfused RBC unit] with TBV=Total Blood Volume and RBC= red blood cell (1 RBC unit = 500 ml with hematocrit=30%).
时间窗: at day 5
次要结局
未报告次要终点
研究者
研究点 (4)
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