Tranexamic Acid in Major Orthopedic Surgery: Comparison of 3 Dosage Regimen
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 210
- 主要终点
- Perioperative bleeding
研究概览
简要总结
Tranexamic acid has been shown to be effective in reducing blood loss and transfusion in orthopedic surgery. It remains unknown the ideal therapeutic regimen. The goal of this study is to compare 3 dosage regimen of tranexamic acid in patients submitted to major orthopedic surgery.
详细描述
There is ongoing debate, however, around optimal perioperative tranexamic acid dosing, which varies widely.
A large number of studies comparing tranexamic acid to placebo, overall blood loss and transfusion requirements are both reduced by ≈30%. A well designed tranexamic acid trial will provide answers to the best regimen dosage for perioperative tranexamic acid use. It will benefit patients by reducing allogeneic transfusions and their associated risks and costs, thus adding value to the care delivered.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 anos
- •Total ankle arthroplasty
- •Total knee arthroplasty
- •Weight >50 kilogram
排除标准
- •Allergy and Hypersensitivity to tranexamic acid
- •Thromboembolic events history
- •Acute kidney injury, Glomerular Filtration Rate < 50 ml/min
- •Coagulation disorders
- •Surgical reintervention
- •Blood transfusion refusal
研究组 & 干预措施
intra-op single dose
intra-operative single dose of tranexamic acid
干预措施: Tranexamic Acid (Drug)
intra-op dose and additional dose
intra-operative dose of tranexamic acid and additional dose 3 hours after
干预措施: Tranexamic Acid (Drug)
intra-op dose and perfusion
intra-operative dose of tranexamic acid followed by a continuous infusion during 6 hours.
干预措施: Tranexamic Acid (Drug)
结局指标
主要结局
Perioperative bleeding
时间窗: postoperative day 2
perioperative blood loss measured in mililiters (mL)
次要结局
未报告次要终点
研究者
Angela Sa
MD
CUF Santarém Hospital