Do Patients Who Are Treated With Tranexamic Acid Loose Les Blood, Comparing to Patients Who Are Not Treated, During Vaginal Hysterectomy? a Randomized Control Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Mean objective assessment of blood loss
研究概览
简要总结
This is a randomized control, double-blind study in which women who are about to go an elective vaginal hysterectomy are offered to participate.
Patients will be randomly assigned to one of two groups: the tranexamic acid group, in which 1 gram of tranexamic acid (Hexakapron) is administered intravenously before surgery, and the control group, in which patients will receive 10 ml of normal saline 0.9% intravenously.
详细描述
This is a randomized control, double-blind study in which women who are about to go for an elective vaginal hysterectomy are offered to participate.
Patients will be randomly assigned to one of two groups: the tranexamic acid group, in which 1 gram of tranexamic acid (Hexakapron) is administered intravenously before surgery, and the control group, in which patients will receive 10 ml of normal saline 0.9% intravenously.
A nurse will prepare the solution according to the randomization and will handle it to the anesthesiologist.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •*Women in general good health (defined as American Society of Anesthesiologists grade 1-2) who are about to undergo elective vaginal hysterectomy indicated by pelvic organ prolapse (POP).
排除标准
- •allergy to TXA
- •familial or personal history of hypercoagulability disorder or thromboembolic events
- •impaired renal function or hematuria
- •patients receiving antithrombotic therapy
- •additional concurrent abdominal/ laparoscopic procedures
- •malignancy
- •Post-assignment exclusion will be executed in cases of conversion to laparotomy/ laparoscopy.
研究组 & 干预措施
Tranexamic acid arm
One gram of tranexamic acid (Hexakapron) is administered intravenously before surgery.
干预措施: Tranexamic acid (Drug)
Placebo arm
patients will receive 10 ml of normal saline 0.9% intravenously.
干预措施: Placebo (Drug)
结局指标
主要结局
Mean objective assessment of blood loss
时间窗: Immediately after surgery
Objective assessment of blood loss is calculated by subtraction the weight of used pads after the surgery from the preoperative weight (blood lost during surgery will be absorbed by pads only, without using suction); 1 g of absorbed fluid will be converted to 1 mL of blood.
次要结局
- Mean subjective blood loss (SBL)(Immediately after surgery)
- Mean difference in hemoglobin levels before and after surgery(One day after surgery)
- The number of patients who need blood products transfusion(30 days after surgery)
- The size of pelvic hematoma after surgery(One day after surgery)
研究者
Ohad Gluck
Senior gynecologist, Principal Investigator, Associated Professor
Wolfson Medical Center