Topical Versus Intravenous Tranexamic Acid in Total Knee Arthroplasty: a Randomized Clinical Trial With 90 Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 90
- 主要终点
- Blood loss
研究概览
简要总结
This clinical trial investigated two different routes of administration of tranexamic acid in total knee arthroplasty: topical compared to intravenous.
详细描述
Intravenous administration of tranexamic acid (TA) is common in orthopedic surgery. The ideal dose and administration route of the drug in total knee arthroplasty (TKA) is under investigation.
The objective of this randomized clinical trial was to verify differences between topical and intravenous administration of TA in TKA regarding blood loss and coagulation variables.
Patients undergoing TKA were randomized to receive TA intravenously (20 mg in 100 ml of saline), topically (1.5 g in 50 ml of saline, sprayed over the operated site, before closure) or intravenous saline (100 ml). Suction drains were maintained for 48 hours, in order to measure blood loss. Data analysis is being undertaken now, in order to compare the two routes of administration of the drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients in need of unilateral total knee arthroplasty (TKA) due to arthrosis, Albach grades III and IV were eligible
排除标准
- •history or identified risk for deep vein thrombosis or pulmonary embolism
- •history of coagulation or cardiovascular disorders
- •vascular diseases
- •pregnancy
- •current use of anticoagulation drugs
- •previous orthopedic surgery in the legs.
研究组 & 干预措施
Topical group
Intervention: Tranexamic Acid - topical. Topical administration of a solution of 1.5 g of tranexamic acid (50 mg/ml, Transamin, Zydus Nikkho) diluted in 50 ml of saline (at 0.9%), sprayed over the operated area, covering it for 5 minutes, before the tourniquet release.
干预措施: Tranexamic Acid - topical (Drug)
Intravenous group
Intervention: Tranexamic Acid - intravenous Intravenous injection of 20 mg/kg of tranexamic acid, diluted in 100 ml of saline at 0.9%, administered with anesthesia in 10 minutes.
干预措施: Tranexamic Acid - intravenous (Drug)
Placebo
Intervention: intravenous injection of 100 ml of saline solution also administered with anesthesia in 10 minutes.
干预措施: Placebo (Drug)
结局指标
主要结局
Blood loss
时间窗: up to 48 hours from the end of surgery, with drained volume registered every 6 hours.
Volume of blood loss in the suction drain device after TKA surgery
次要结局
- Thrombosis(up to 15 days after surgery)
- Need for transfusion(during or after surgery, during hospital stay (hospital discharge took place in four days, in average))
研究者
Ari Zekcer
MD, PhD
Irmandade da Santa Casa de Misericordia de Sao Paulo