2024-517398-26-01招募中2 期
Evaluation of intra articular Tranexamic acid for reduction of total blood loss in total hip arthroplasty
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Total blood loss 24 hours after the operation
研究概览
简要总结
In this RCT-study we investigate the potential additive effect of intraarticular injected Tranexamic Acid (TXA) for the total blood loss in unilateralt total hip arthroplasty in addition to conventional treatment with IV TXA. The intervention group will be given IV TXA at the start of surgery + injection of TXA into the joint (end surgery) VS. TXA at the start of surgery + injection af equal volume of NaCl (placebo).Primary endpoint is total blood loss 24 hours after surgery.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Undergoing surgery for unilateral total hip arthroplasty
- •Able to give ones consent either verbally or written.
排除标准
- •Operation performed in general anaesthesia
- •Patients who are not able to speak and understand Danish
- •Patients who refuse to receive blood products
- •Present acute thromboembolic event (DVT, AMI, cerebral infarction, pulmonary embolism)
- •Disseminated intravascular coagulation (DIC) or active thromboembolic disease
- •Active cancer disease
- •Had one of the following type of trauma or surgeries in the affected hip: Hip fractures, periacetabulær osteotomy, femurosteotomy, trochanterostetomi.
- •Rheumatic arthritis.
- •Allergi to TXA
- •In treatment with the following anticoagulatia: ADP receptorinhibitors, vitamin-K antagonist(within 5-7 days before the operation). Factor Xa inhibitors, thrombine-inhibitors
- •Use of oral anticonceptiva
- •Known with thrombophilia
- •Reduced kidney function (GFR <45 ml/hour)
- •Participated in a clinical trial within the last 30 days
- •Alcoholism and morphinism
- •Females: menstruation within the last 12 months
结局指标
主要结局
Total blood loss 24 hours after the operation
Total blood loss 24 hours after the operation
次要结局
- Total blood loss on the morning af the 2nd postoperative day.
研究者
Christian Skovgaard Nielsen
Scientific
Hvidovre Hospital
研究点 (1)
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