TRANEXAMIC ACID IN PATIENTS UNDERGOING TOTAL HIP ARTHROPLASTY IN A BRAZILIAN REFERENCE ORTHOPEDIC CENTER: A RANDOMIZED CONTROLLED TRIAL
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 256
- 试验地点
- 1
- 主要终点
- Blood transfusion rate
研究概览
简要总结
This study aims to analyze the efficacy of intravenous tranexamic acid (TXA) in patients undergoing total hip arthroplasty (THA).
详细描述
This was a prospective, experimental, randomized, controlled study of 308 consecutive patients who underwent primary THA from December 2013 to March 2014. 256 volunteers remained in the study, 128 were treated 15 mg/kg intravenous bolus of TXA and 128 did not receive the medication. Participants were followed up at 3 weeks, 3 months, 6 months, 1 year, and then annually after surgery.
The use of TXA resulted in lesser reduction in hemoglobin and hematocrit levels, reduced blood loss, blood transfusion rate, volume of blood products, and stay length even in risk factor patients.
TXA protects risk factor patients against intra and postoperative bleeding and reduces transfusion rates.
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, Care Provider)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Consecutive patients who need total hip replacement were included in the initial sample. There was no age limit or restriction regarding gender for admission to the study.
排除标准
- •Patients who underwent previous surgery in the same joint, evidence of joint infection, congenital or acquired coagulopathies, active intravascular coagulation, acute occlusive vasculopathy, hypersensitivity to TXA, chronic use of oral and steroid anticoagulants, history of severe or moderate allergy to plasma transfusion, chronic heart disease, malignant neoplasms and autoimmune diseases, patients who needed bone graft or underwent hip arthroplasty revision surgeries, and who did not consent to participate in the study
研究组 & 干预措施
TXA
Performed an intravenous bolus administration of 15 mg/kg of TXA to the volunteers after the end of the anesthesia and 15 minutes prior to skin incision.
干预措施: Tranexamic Acid Injectable Solution (Drug)
Control
This group underwent the same procedures of the TXA group, excepting the preoperative administration of the medication.
干预措施: Placebo - Concentrate (Drug)
结局指标
主要结局
Blood transfusion rate
时间窗: 5 days
Hemoglobin drop
时间窗: 24 hours post operative
Hematocrit drop
时间窗: 24 hours post operative
Operative blood loss
时间窗: 24 hours post operative
次要结局
- Length of stay in hospital(7 days)
- Thromboembolic efects(1 year)
- Systemic adverse events(1 year)
研究者
Osamu de Sandes Kimura
M.D.
Instituto Nacional de Traumatologia e Ortopedia