Efficacy of Tranexamic Acid in Reducing Myomectomy Associated Blood Loss in Federal Teaching Hospital Abakaliki
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Postoperative Haemoglobin concentration
研究概览
简要总结
to determine safety and efficacy of Tranexamic Acid in reducing blood loss during Myomectomy in our institution.
详细描述
A double blinded randomized controlled trial in which cases were given 1000mg intravenous tranexamic acid into 1L of intravenous normal saline and control were given 10mls of placebo water for injection into same amount of intravenous fluid. outcome of both groups in terms of intraoperative blood loss, duration of surgery, postoperative packed cell volume and total blood loss with risk of blood transfusion were then determined.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
double blind
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •non-pregnant women with symptomatic myomas women with no known contraindication to tranexamic acid
排除标准
- •past history of thromboembolic disorder, ischaemic heart disease, malignancy or liver disease
研究组 & 干预措施
group A: Cases that had tranexamic acid infusion
Group A had perioperative tranexamic acid infusion at the rate of 100mls per hour
干预措施: Tranexamic acid (Drug)
Group B: Control
control were given perioperative placebo at the rate of 100mls per hour
干预措施: Tranexamic acid (Drug)
结局指标
主要结局
Postoperative Haemoglobin concentration
时间窗: one year
Average Postoperative Haemoglobin concentration of both groups were determined
Average duration of surgery in each group
时间窗: one year
Average duration of Surgeries were calculated for each group
Mean intraoperative Blood loss
时间窗: one year
The mean intraoperative blood loss was calculated for both groups
次要结局
- Blood Transfusion(One year)
研究者
Olaleye Ayodele Adegbite
Dr
Alex Ekwueme Federal University Teaching Hospital