Study of the Noninferiority of an Oral vs Intravenous Administration of Tranexamic Acid in Total Hip Arthroplasty
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 230
- 试验地点
- 1
- 主要终点
- Total blood loss
研究概览
简要总结
To find noninferiority relationship between oral and intravenous administration of tranexamic acid on peroperative and postoperative blood loss and serum concentration during primary total hip arthroplasty.
详细描述
Tranexamic acid is an anti-fibrinolytic drug, recommended in total hip arthroplasty to reduce peroperative and postoperative hemorrhagic complications. The original character of our study lies in the serum dosage of tranexamic acid, allowing to correlate the primary objective (blood loss) with this one. The investigators will focus on the reduction of the risks associated with the administration of intravenous medicines, the economic aspect and the ease of use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double blinded randomized controlled trial. Patient, anesthesiologist and surgeon are blinded.
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA physical status 1, 2 and 3 scheduled for primary total hip arthroplasty
排除标准
- •Renal failure with serum creatinine level higher than 1,40 mg/dL
- •Thromboembolic events in last 12 months before surgery
- •Pregnancy
- •Congenital or acquired coagulation diseases
- •History of gastric surgery that could lead to malabsorption
- •Diabetic gastro-paresis
研究组 & 干预措施
Oral Tranexamic Acid
128 patients scheduled for primary total hip arthroplasty
干预措施: Tranexamic Acid Oral Product (Drug)
Intravenous Tranexamic Acid
128 patients scheduled for primary total hip arthroplasty
干预措施: Tranexamic acid injection (Drug)
结局指标
主要结局
Total blood loss
时间窗: First 48 hours after surgery
Peroperative (suction) and postoperative (drainage) total blood loss
次要结局
- Incidence of thromboembolic complications(72 hours after surgery)
- Serum concentration of tranexamic acid(4 hours after intravenous administration)
- Incidence of blood transfusion(72 hours after surgery)
- Length of hospitalisation stay(1 week after surgery)
- Serum hemoglobin variation(72 hours after surgery)
研究者
Jean François Brichant
Head of Anesthesiology Departement
University of Liege