Multiple Intravenous Tranexamic Acid Doses Can Reduce Postoperative Blood Loss and Improve the Functional Outcome in Total Knee Arthroplasty Without Tourniquet: a Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
- 主要终点
- Platelet count change
研究概览
简要总结
Multiple intravenous Tranexamic Acid doses can reduce postoperative blood loss and improve the functional outcome in total knee arthroplasty without tourniquet: a randomized controlled study.
详细描述
A total of 180 patients undergoing TKA for knee osteoarthritis were stratified in three equal groups. All surgeries were performed under spinal anesthesia, without tourniquet and patients should be in agreement with the established inclusion/exclusion criteria. Group A (60 patients) received 1g of IV TXA, Group B (60 patients) received an additional dose of IV TXA and Group C (60 patients) received three doses of IV TXA. The measured outcomes were the Hemoglobin (Hb) decrease, the transfusion rate, the functional, quality of life (QoL) and pain assessment based on their corresponding scoring system.
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
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •varus deformity less than 10o
- •lack of extension not more than 10o
- •flexion of at least 90o.
排除标准
- •uncontrolled medical diseases/comorbidities
- •allergy and/or hypersensitivity to TXA
- •a known history of thromboembolic disease, cardiovascular disease
- •coronary or vascular stent placed within the past 12 months
- •cerebral vascular disease (a history of stroke)
- •subarachnoid hemorrhage
- •preoperative coagulopathy (a platelet [PLT] count <150,000/mm3 or an international normalized ratio greater than 1.5
- •preoperative renal or hepatic dysfunction
- •retinal vein or artery occlusion
- •patients with anemia (<12 g/dL for female, <13 g/dL for male)
研究组 & 干预措施
Group A - Tranexamic Acid
1 dose of IV TXA (15mg/kg) in 100-ml normal saline, 10 minutes before incision, administered during the induction of the anesthesia
干预措施: Tranexamic Acid (Drug)
Group B - Tranexamic Acid
1 dose of IV TXA (15mg/kg) in 100-ml normal saline, 10 minutes before incision and an additional dose of IV TXA (15mg/kg) in 100-ml normal saline 3 hours after skin incision
干预措施: Tranexamic Acid (Drug)
Group C - Tranexamic Acid
1 dose of IV TXA (15mg/kg) in 100-ml normal saline, before incision and two additional doses of IV TXA (15mg/kg) in 100-ml normal saline 3 and 6 hours after skin incision respectively
干预措施: Tranexamic Acid (Drug)
结局指标
主要结局
Platelet count change
时间窗: 24 hours, 48 hours, 96 hours
Platelet count increase/decrease/change during the 1st,2nd and 4th day
hemoglobin change
时间窗: 1st,2nd and 4th post-operative day
Hemoglobin decrease/change during the four post-operative days
Need for trasfussion
时间窗: 96 hours
Transfussion rate/quantity in 3rd post-op day
Blood loss
时间窗: 96 hours
calculated total blood loss (TBL) the 4th post-op day
次要结局
- VAS pain (analogue pain scale)(2nd and 4th post op days + 6th week and 12th week)
- Knee Society Score (KSS) KSS(2nd and 4th post op days + 6th week and 12th week)
- Function Knee Society Score(2nd and 4th post op days + 6th week and 12th week)
- EuroQol(2nd and 4th post op days + 6th week and 12th week)
研究者
Tzatzairis Themistoklis
Principal investigator Dr. Tzatzairis Themistoklis
Democritus University of Thrace