Tranexamic Acid in Surgery of Advanced Ovarian Cancer - a Prospective Randomized Double Blind Placebo Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- Perioperative Bleeding Volume
研究概览
简要总结
The purpose of the study is to determine if a standardized single dose tranexamic acid given intravenously immediately preoperatively reduces the perioperative bleeding volume and reduces the need of blood transfusion in women undergoing surgery for advanced ovarian cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females ages 18 or older with a pelvic or abdominal tumor suspected or histopathologically proven ovarian cancer FIGO stage II-IV who are undergoing primary surgery with the intention of performing optimal cytoreductive radical surgery.
- •Understand and speak Swedish
- •Accept participation in the study after written and verbal information and sign informed consent.
排除标准
- •Allergy to tranexamic acid
- •Having had tranexamic acid within the recent 30 days
- •Previous or present episode of thromboembolic events .
- •Previous or present treatment within the recent 3 months with anticoagulant.
- •Previous or present known coagulopathy
- •Myocardial infarction within the previous 12 months or instable angina pectoris which, according to the investigator, may increase the risk for complications significantly in case of a lowering of the hemoglobin.
- •Significant renal failure with serum-creatinine > 250 µmol/l.
- •Severe psychiatric dysfunction or mentally substantially disabled.
研究组 & 干预措施
The Tranexamic acid group
The group of women receiving Tranexamic acid intravenously immediately before the surgery
干预措施: Tranexamic acid (Drug)
The placebo group
The group of women receiving saline solution (0.9% NaCl) intravenously immediately before the surgery
干预措施: 0.9% NaCl solution (Drug)
结局指标
主要结局
Perioperative Bleeding Volume
时间窗: From start of operation to discharge from hospital, up to 5 weeks
Estimation of total blood loss was based on the estimation of the Hb balance method (Brecher, et al.1997) with the assumption that the body blood volume was normalised on the fifth postoperative day. The haemoglobin level was assessed preoperatively and on the fifth postoperative day. The predicted blood volume (PBV, l) was calculated according to the method described by Nadler et al. (1962), using body weight and height. The extravasation of haemoglobin was calculated taking into account allogenic transfused haemoglobin. Total blood loss perioperatively was related to the patient's preoperative haemoglobin value. Blood loss due to haematomas or a reoperation within the first five days after surgery was also considered.
次要结局
- Number of Patients Receiving Blood Transfusions(From start of operation to discharge from hospital, up to 5 weeks)
- Number of Units of Red Blood Cells (RBC) Transfused(From start of operation to discharge from hospital, up to 5 weeks)
- Median Number of Transfused Units of Red Blood Cells (RBC)(From start of operation to discharge from hospital, up to 5 weeks)
- Number of Patients With Clinically or Radiologically Verified Thromboembolic Events Within 5 Weeks Postoperatively(From time of operation to 5 weeks postoperatively.)
研究者
Preben Kjolhede, MD, professor
Associate professor
University Hospital, Linkoeping