Triple Tourniquets With or Without IV Tranexamic Acid for Reducing Blood Loss at Open Myomectomy: A Double-blinded Randomized Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Mean amount of intraoperative blood loss
研究概览
简要总结
In this study, the investigators will investigate the effectiveness of an intravenous tranexamic acid plus triple tourniquets compared with triple tourniquets alone for the reduction of blood loss at the time of myomectomy
详细描述
An RCT investigated the efficacy of intravenous tranexamic acid (TA) during abdominal myomectomy. The study was unable to demonstrate any significant impact on blood loss, duration of surgery or need for blood transfusionHemostatic tourniquets to reduce intra-operative bleeding have long been available, but data on their efficacy from controlled trials are lacking. The investigators set out to evaluate the use of triple tourniquets plus tranexamic acid in controlled conditions and for the first time to investigate the hypothesis that adding tranexamic acid to tourniquet around the uterine artery reduces postoperative bleeding from the uterine incisions, a well-recognized sequel to surgery
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
A double-blinded randomized placebo-controlled trial
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients presenting for abdominal myomectomy with documented uterine fibroids on ----pelvic imaging
- •Age ≥ 18 years and ≤ 50 years
- •Pre-operative hemoglobin >8 g/dl
- •Ability to understand and the willingness to sign a written informed consent.
- •Admissible medical/surgical history
- •Five or less symptomatic uterine myomas
- •All myomas are subserous or intramural.
- •Uterine size less than 24 weeks of pregnancy
排除标准
- •Patients who have had a prior abdominal myomectomy
- •Post-menopausal women
- •Patients with known bleeding/clotting disorders
- •Patients with a history of gynecologic malignancy
- •Hypertension.
- •Cardiac and Pulmonary Diseases.
- •Obesity (body mass index > 30 kg/m2).
- •History of allergic reactions attributed to misoprostol
- •Cases that will require intraoperative conversion of myomectomy to hysterectomy
研究组 & 干预措施
Triple tourniquets plus TA
A number 1 polyglactin suture was tied around the cervix to occlude the uterine arteries, and polythene tourniquets were tied around the infundibulopelvic ligament to obstruct the ovarian vessels.plus1-gram tranexamic acid (10 ml) in 100 ml saline infusion
干预措施: Triple tourniquets (Procedure)
Triple tourniquets plus TA
A number 1 polyglactin suture was tied around the cervix to occlude the uterine arteries, and polythene tourniquets were tied around the infundibulopelvic ligament to obstruct the ovarian vessels.plus1-gram tranexamic acid (10 ml) in 100 ml saline infusion
干预措施: TA (Drug)
Triple tourniquets plus placebo to TA
A number 1 polyglactin suture was tied around the cervix to occlude the uterine arteries, and polythene tourniquets were tied around the infundibulopelvic ligament to obstruct the ovarian vessels.plus placebo to 1-gram tranexamic acid (10 ml) in 100 ml saline infusion
干预措施: Triple tourniquets (Procedure)
Triple tourniquets plus placebo to TA
A number 1 polyglactin suture was tied around the cervix to occlude the uterine arteries, and polythene tourniquets were tied around the infundibulopelvic ligament to obstruct the ovarian vessels.plus placebo to 1-gram tranexamic acid (10 ml) in 100 ml saline infusion
干预措施: placebo to TA (Other)
结局指标
主要结局
Mean amount of intraoperative blood loss
时间窗: intraoperative
measure the mean amount of intraoperative blood loss by gravimetric methods
次要结局
- The number of patients needs for blood transfusion(24 hours post delivery)
研究者
hany farouk
Principal Investigator
Aswan University Hospital