Efficacy and Safety of Tranexamic Acid in Cytoreductive Surgery for Ovarian Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 151
- 试验地点
- 1
- 主要终点
- operative and postoperative blood loss
研究概览
简要总结
Tranexamic acid has been used in surgery for more than 30 years. It's effect on reducing bleeding and blood transfusing has been demonstrated.
In our hospital, the amount of cytorsductive surgery for ovarian cancer is big. During the perioperation , bleeding probability is high, and the supply of blood products is limited. In order to reduce bleeding, we're planning to use tranexamic acid in the operations.
In this experiment, we will observe the efficacy of tranexamic acid in cytoreductive surgery for ovarian cancer, find the best dosage which can reach the desired effect, and the possible side-effect.
详细描述
We performed a single blind, prospective, randomised control trial (RCT) . The patients randomised assigned to three groups. Low dose TXA, high dose TXA or a placebo of IV saline which will be infused prior to skin incision in patients undergoing elective cytorsductive surgery for ovarian cancer .
Intraoperative blood loss will be estimated by the volume in the suction drains and by weighing the swabs. Postoperative blood loss will be estimated by the volume in the drains.
The other secondary outcomes will be inclued perioperation transfusion volume, thromboembolic complications, ICU length of stay (LOS), hospital LOS, adverse thrombogenic events within 30 days, 30-day all-cause readmission and so on.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •sign the informed consent
- •Aged 20-70 years
- •ovarian cancer patients, staged IIIB - C or above
- •ASA I - II
排除标准
- •tranexamic acid allergy
- •pregnancy and lactation
- •only lymph node metastasise
- •history of mental disorder, immune system disorder
- •history of epilepsy, dyschromatopsia
- •history of renal insufficiency
- •thrombosis related disease
- •Hb < 90 g/dL
- •using anticoagulant drugs (not including aspirin discontinuation 1 week
- •having participated in other clinical trials, or refusing to join the research.
研究组 & 干预措施
high dose TXA
TXA will be given as a 20mg/kg bolus followed by infusion of 5mg/ kg/hr per our anesthesia protocol
干预措施: Tranexamic Acid (Drug)
low dose TXA
TXA will be given as a 10mg/kg bolus followed by infusion of 1mg/ kg/hr per our anesthesia protocol
干预措施: Tranexamic Acid (Drug)
normal saline
saline will be given as a 4ml/kg bolus followed by infusion of 1ml/ kg/hr per our anesthesia protocolprotocol4ml/kg
干预措施: normal saline (Drug)
结局指标
主要结局
operative and postoperative blood loss
时间窗: up to 8 days
the amount of bleeding
次要结局
未报告次要终点
研究者
Jun Zhang
Director of the department of anaesthesiology, Shanghai cancer center
Fudan University