Perioperative Management With Ferric Carboxymaltose and Tranexamic Acid to Reduce Transfusion Rate in Gynaecological Carcinoma Surgery: a Single-blind, Mono-centre, Randomized Trial
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- number of all perioperative (intraoperative and postoperative) administered RBC transfusions
研究概览
简要总结
This study is to determine the effect of perioperative treatment with intravenous iron and tranexamic acid on the reduction of intraoperative and postoperative RBC transfusions in gynaecological carcinoma patients undergoing abdominal surgery.
详细描述
Radical abdominal surgery often leads to intraoperative bleeding frequently exceeding 1000 ml and approximately 50% of women undergoing this surgery require blood transfusion. Perioperative blood transfusions have been shown to increase of length of stay, surgical complications, postoperative morbidity and mortality. There are a few data on the reduction in red blood cell count (RBC) transfusions using perioperative management with intravenous iron and tranexamic acid in women with gynaecological carcinoma surgery. This study is to determine the effect of perioperative treatment with intravenous iron and tranexamic acid on the reduction of intraoperative and postoperative RBC transfusions in gynaecological carcinoma patients undergoing abdominal surgery.
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
- Double (Participant, Outcomes Assessor)
盲法说明
The study will be blinded to participants and statistician conducting the data analysis. The physicians and nurses who will perform this infusion will not be blinded.
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
- •informed consent as documented by signature
- •women with gynaecological carcinoma surgery with hemoglobin level between 90-120 g/I and serum ferritin < 100 µg/I (or ferritin index < 3.19) at recruitment
- •pregnancy test negative in women younger than 50 years
排除标准
- •known hypersensitivity or allergy to ferric carboxymaltose or tranexamic acid
- •history or present laboratory signs of bleeding disorders, coagulopathy or thromboembolic events
- •history of myocardial infarction within the last year, present unstable angina or severe coronary disease
- •increased plasma creatinine levels above 250 µmol/I
- •inability to follow the procedures of the study (language problems, severe psychiatric or mental disorders)
- •iron overload
- •current administration of intravenous iron or previous intravenous iron therapy or blood transfusion within three months
- •date of scheduled surgery is outside 28 days after the date of recruitment
- •other clinically significant concomitant disease states (e.g., hepatic dysfunction, cardiovascular disease, etc.)
- •participation in another study with investigational drug within the 30 days
- •enrolment of the investigator, his/her family members, employees and other dependent persons.
研究组 & 干预措施
ferric carboxymaltose
ferric carboxymaltose 20 mg/kg (with a maximum dose of 1000 mg ferric carboxymaltose in a single Infusion) (Ferinject® 1000 mg/20 ml) will be administered between day -27 and day -7.
干预措施: ferric carboxymaltose (Drug)
tranexamic acid
tranexamic acid 10mg/kg (Tranexam OrPha 1000 mg/10 ml, OrPha Swiss GmbH, Küsnacht, Switzerland) will be administered 15 -30 minutes prior to surgery followed by infusion of tranexamic acid through syringe pump (1 mg/kg/h) till 4 h postoperatively
干预措施: tranexamic acid (Drug)
ferric carboxymaltose and tranexamic acid
ferric carboxymaltose (Ferinject® 1000 mg/20 ml) between day -27 and day
-7 and tranexamic acid (Tranexam OrPha 1000 mg/10 ml) 15-30 minutes prior to surgery followed by Infusion of tranexamic acid through syringe pump (1 mg/kg/h) till 4 h postoperatively will be administered.
干预措施: ferric carboxymaltose and tranexamic acid (Drug)
结局指标
主要结局
number of all perioperative (intraoperative and postoperative) administered RBC transfusions
时间窗: day of surgery until follow up visit 5 (up to 28 days)
number of all perioperative (intraoperative and postoperative) administered RBC transfusions (the absolute rate of RBC transfusions)
次要结局
- change in hemoglobin level(day of surgery until follow up visit 5 (up to 28 days))
- blood loss measured during surgery (ml)(day of surgery)
- duration of hospitalisation (days)(from admission to discharge date (up to 56 days))
- rate of transfused women with gynaecological carcinoma during and/or after surgery(day of surgery until follow up visit 5 (up to 28 days))
- rate of other blood product transfusions(day of surgery until follow up visit 5 (up to 28 days))
- requirement of additional local or systematic haemostatic therapy (descriptive)(day of surgery until follow up visit 5 (up to 28 days))
- duration of surgery (minutes)(day of surgery)
- number of postoperative complications(day of surgery until follow up visit 5 (up to 28 days))
- postoperative mortality(day of surgery until follow up visit 5 (up to 28 days))