Tranexamic Acid for Blood Loss Minimization in Endoscopic Pituitary Surgery: A Double-Blind Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Mean Blood Loss
研究概览
简要总结
This trial is to determine the effect of Tranexamic Acid (TXA) on blood loss during endoscopic pituitary surgery. The hypothesis of this study is that TXA will reduce blood loss during surgery compared to a placebo. To answer this hypothesis, the investigators are conducting a randomized controlled trial in which half of participants will receive TXA and half will receive placebo (saline) in a double blind fashion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The only staff with access to randomization codes will be our study statistician who created the randomization table and our investigational drug services pharmacy who is preparing the investigational product.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Undergoing endoscopic pituitary surgery at UNC
排除标准
- •Clival invasion
- •Giant pituitary tumor (>4 cm)
- •Revision pituitary surgery
- •Prior sinus surgery
- •Lund McKay score > 3
- •Active thromboembolic disease
- •Coagulopathy
- •Concomitant pro-thrombotic medications
- •Concomitant use of anti-coagulants or anti-platelet agents
- •Subarachnoid hemorrhage
- •History of severe hypersensitivity to Tranexamic Acid
研究组 & 干预措施
Tranexamic Acid
Participants in the Tranexamic Acid arm will receive a dose of Tranexamic Acid.
干预措施: Tranexamic acid (Drug)
Placebo
Patients in the placebo arm will receive a saline placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
Mean Blood Loss
时间窗: Time between incision and surgical closure, an average of 3 to 3.5 hours
Blood loss measured in mL
次要结局
- Intra-operative Surgical Visibility - Wormald Scale Score(Duration of operation, up to 4 hours)