Evaluation of Intraarticular Tranexamic Acid to Reduction of Total Blood Loss Following Knee-Arthroplasty - A Randomized, Prospective, Placebo-Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Total estimated blood loss
研究概览
简要总结
A randomized, prospective, placebo-controlled study which aims to evaluate the effect of combined intraarticular and intravenous Tranexamic acid on total blood loss following unilateral knee replacement versus only intravenous tranexamic acid.
详细描述
Intravenous (IV) Tranexamic acid is already well-established and well-documented regarding significant effect on reducing blood loss following knee replacement. A few studies more shown a similar effect of intraarticular (IA) injected Tranexamic acid into the knee joint at the end of surgery for knee replacement.
In this study investigators therefore investigate the possible combined effect of added intraarticular tranexamic acid to conventional intravenous Tranexamic acid.
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
- Double (Participant, Investigator)
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
- •> 18 years old
- •Unilateral knee replacement
- •Must be able to give oral and written consent
排除标准
- •General Anesthetized
- •Allergic to Tranexamic acid
- •In treatment with the following anticoagulants: Adenosine diphosphate receptor inhibitors or vitamin K antagonist within in the last 5 days. Factor Xa inhibitor and thrombin inhibitor.
- •Use of oral anticonceptive.
- •Reduced kidney function (S-creatinine > 120 micromol/L)
- •Medicine or alcohol abuse
- •Females with menstruation within the last 12 mounts.
- •Any kind of cancer disease
- •Rheumatoid arthritis
- •Have participated in a clinical trial within the last 30 days.
研究组 & 干预措施
IA Tranexamic acid + IV Tranexamic Acid
3 gram of Tranexamic acid diluted into 30 ml Saline Water injected into the knee capsula after ended surgery + 1 g of Tranexamic acid injected intravenous at the start of surgery.
干预措施: Tranexamic Acid (Drug)
IA Saline Water + IV tranexamic Acid
30 ml Saline Water injected into the knee capsula after ended surgery + 1 g of Tranexamic acid injected intravenous at the start of surgery.
干预措施: Saline water (Drug)
IA Saline Water + IV tranexamic Acid
30 ml Saline Water injected into the knee capsula after ended surgery + 1 g of Tranexamic acid injected intravenous at the start of surgery.
干预措施: Tranexamic Acid (Drug)
结局指标
主要结局
Total estimated blood loss
时间窗: 24 hours surgery
次要结局
- Thromboembolic complications(90 days postoperative)
- Total estimated blood loss(2 days after surgery)
- Blood transfusion(while hospitalized expected 3 days.)
研究者
Christian Skovgaard Nielsen
MD
Hvidovre University Hospital