Does Oral Administration of Tranexamic Acid in Anterior Cruciate Ligament Arthroscopic Surgery Reduce Postoperative Haemarthrosis and Improve Functional Prognosis?
试验速览
- 阶段
- 4 期
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Assessment of haemarthrosis
研究概览
简要总结
To find superiority relationship between oral and intravenous administration of tranexamic acid on peroperative and postoperative blood loss, haemarthrosis prevalence and improvement functional prognosis in anterior cruciate ligament arthroscopy.
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
Patient, anesthesiologist and surgeon are blinded
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary arthroscopic surgery for anterior cruciate ligament reconstruction
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
52 patients scheduled for primary anteriori cruciate ligament surgery by arthroscopy
干预措施: Oral tablet (Drug)
Placebo
52 patients scheduled for primary anteriori cruciate ligament surgery by arthroscopy
干预措施: Placebo (Drug)
结局指标
主要结局
Assessment of haemarthrosis
时间窗: First 24 hours after surgery
Postoperative (drainage) blood loss
次要结局
- Postoperative pain(15 days after surgery)
- Clinical evaluation of functional recovery(15 days after surgery)
- Length of hospital stay(First 30 days after surgery)
研究者
Jean François Brichant
Head of Anesthesiology Departement
University of Liege