Efficacy of Topical Tranexamic Acid Versus Intravenous Administration to Reduce Blood Transfusion Rate in Total Knee Arthroplasty Surgery: Phase III, Unicentric, Controlled,Double Blind, Randomized Non Inferiority Clinical Trial.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 79
- 试验地点
- 1
- 主要终点
- Blood transfusion rate
研究概览
简要总结
The main objective is to evaluate the efficacy and safety of topical Tranexamic Acid (TA) to reduce the blood transfusion rate in total knee arthroplasty. The secondary endpoints are to estimate the visible blood loss at 24 hours after surgery, and invisible blood loss through serial counting of Hb/Htc. Methodology. TRANEX1 is a phase III, unicentric, controlled, randomized, double blind clinical trial that compare efficacy and safety of topical TA versus intravenous TA in a multimodal protocol, with no-inferiority criteria(n=79).
详细描述
The groups will be compared by ITT and PP. The non-inferiority would be estimated by comparing the confidence interval using the traditional test, and Wilson test.
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
- •Adult patients (greater than 18 years old)
- •Patients scheduled for primary unilateral knee arthroplasty
- •Patients for La Paz- Cantoblanco Hospital, Madrid, Spain
排除标准
- •Patients that refuse to sign the Inform Consent
- •Allergy to tranexamic acid
- •Major comorbidities: Severe ischemic heart disease(class III and IV of New York Heart Association); sleep apnea syndrome; severe EPOC; renal dysfunction (plasma creatinine>2mg/dL if mens and >1.8mg/dL if woman); or hepatic disfunction.
- •Coagulopathy (preoperative platelet count <150,000/mm3, INR>1.4, prolonged PPT(>1.4 x normal)
- •History of thromboembolic disease: CVA, DVT, PE
- •Blood dyscrasias
- •Retinopathy (disturbances of color vision)
- •Jehovah's witnesses
- •Pregnancy
- •Breastfeeding
- •Been participating or been participated a year ago in another clinical trial
研究组 & 干预措施
Experimental
- Topical administration of 3g of Tranexamic Acid in 100mL of normal saline (0.9% sodium chloride) as follow:
- 50mL by irrigation before wound closure
- 50mL by intraarticular administration (Drenofast) after wound closure.
- Intravenous administration of Normal saline (0.9% sodium chloride) as follow:
- 100mL before tourniquet realised
- 100mL 3 hours after surgery
干预措施: Tranexamic Acid (Drug)
Comparator
- Topical administration of Normal saline (0.9% sodium chloride) as follow:
- 50mL by irrigation before wound closure
- 50mL by intraarticular administration (Drenofast) after wound closure
- Intravenous administration of two dosis of Tranexamic Acid as follow:
- 15mg/kg of Tranexamic Acid in 100mL of normal saline (0.9% sodium chloride), before tourniquet realised
- 15mg/kg of Tranexamic Acid in 100mL of normal saline (0.9% sodium chloride), 3 hours after surgery
干预措施: Tranexamic Acid (Drug)
结局指标
主要结局
Blood transfusion rate
时间窗: participants will be followed for the duration of hospital stay, an expected average of 5 days
Number of transfused patients in each arm/Total number of patients in each arm
次要结局
- Prevalence of drug-related adverse events(participants will be followed for the duration of hospital stay, an expected average of 5 days)
- Surgery infection rate(One month after surgery)
- Range of motion(participants will be followed for the duration of hospital stay, an expected average of 5 days)
- Visible blood loss(24 hours after surgery)
- Invisible blood loss(48 hours after surgery)
- Rate of PE(One month after surgery)
- Rate of DVT(One month after surgery)
- Rate or Thrombophlebitis(One month after surgery)
研究者
Enrique Gómez Barrena
Professor
Hospital Universitario La Paz