Local Tranexamic Acid During Vaginal Hysterectomy to Reduce Blood Loss
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Blood loss during operation - measure in ml
研究概览
简要总结
Assessing the efficiency of Prophylactic use of local tranexamic acid during vaginal hysterectomy to reduce blood loss during operation
详细描述
This randomized control trial will investigate whether local tranexamic acid is efficient for decreasing bleeding during vaginal hysterectomy.
The investigators will randomize local placebo (saline) vs. local 1 gr tranexamic acid; local 1gr tranexamic acid diluted in 10 ml saline and local 10 ml saline at the beginning of surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 20 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •20-90 years old female patients going through vaginal hysterctomy
排除标准
- •massive bleeding during operation due to major vessles injury
- •known coagulopathies
- •sensitivity to tranexamic acid
- •medical need in tranexamic acid administration during operation due to bleeding
研究组 & 干预措施
local tranexamic acid injection to cervix
1 gr of Tranexamic acid diluted in 10 ml saline
干预措施: local tranexamic acid injection (Drug)
local normal saline injection to cervix
20 ml of saline
干预措施: local normal saline injection to cervix (Other)
结局指标
主要结局
Blood loss during operation - measure in ml
时间窗: End of surgery
At the end of the surgery, surgeon will measure the blood in the suction can
次要结局
未报告次要终点
研究者
Yair Daykan
Principal Investigator
Meir Medical Center