The Effectiveness of Tranexamic Acid in Breast Esthetic Surgery.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Blood loss volume
研究概览
简要总结
The investigators prepared a novel tranexamic acid (TXA) study designed to estimate the quantity of blood loss in patients undergoing breast esthetic surgery. This study aims to quantify blood loss during abdominoplasty with and without TXA. The central hypothesis is that TXA administration reduces blood loss and fibrinolysis in breast esthetic surgery patients.
详细描述
Tranexamic acid (TXA) treatment is increasingly emphasized in plastic surgery because TXA inhibits fibrinolysis. Increased clot stability offers the possibility of preventing blood loss (prevention) and mitigating ongoing hemorrhage. TXA therapy has been principally studied in populations; the results of studies in plastic surgery still need to be improved.
Tranexamic acid is an antifibrinolytic agent that acts as a competitive inhibitor at the lysine binding sites of plasminogen and inhibits the ability of protease plasmin to cleave the fibrin clot. In large randomized controlled trials, it has been reported to be effective in decreasing perioperative blood loss in various circumstances, primarily involving trauma patients.
The investigators designed a randomized placebo-controlled trial comparing TXA dosing before incision for breast esthetic surgery. The purpose is to quantify blood loss during plastic surgery with and without TXA.
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)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •women scheduled for breast esthetic surgery
- •ASA 1 or 2
- •age >18 and <75 years
排除标准
- •BMI <20 or >35 kg/m2
- •ASA 3 or > 3
- •medical history of thromboembolism
- •history of hematological disease
- •treatment with aspirin 14 days before the procedure
- •treatment with anticoagulants 5 days before the procedure
- •allergy to tranexamic acid
- •coagulation disorders
研究组 & 干预措施
Placebo
Normal saline for intravenous administration.
干预措施: Placebo (Drug)
Tranexamic acid
Tranexamic Acid for intravenous administration.
干预措施: Tranexamic acid (Drug)
结局指标
主要结局
Blood loss volume
时间窗: 24 hours after surgery
Total blood volume loss will be calculated in milliliters.
次要结局
- Fibrinogen(24 hours after surgery)
- HBG(24 hours after surgery)
- D-dimer(24 hours after surgery)