Blood Loss in Arthroplasty With Oral Versus IV Tranexamic Acid
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Calculated Blood Loss
研究概览
简要总结
The goal of this randomized clinical control trial is to determine whether oral TXA dosing in THA/TKA result in more blood loss and more transfusions compared to IV TXA dosing in patients undergoing THA/TKA under neuraxial anesthesia. The main questions it aims to answer are:
Does oral TXA dosing in THA/TKA result in more blood loss compared to IV TXA dosing?
Does oral TXA dosing in THA/TKA result in more transfusions compared to IV TXA dosing?
Participants will be randomly assigned to either get the Oral TXA (1950mg) or the IV TXA (1g) on their day of surgery. Researchers will compare these groups to see if any differences emerged. 200 THA patients (100 Oral, 100 IV), 200 TKA patients (100 oral, 100 IV).
详细描述
Tranexamic acid (TXA) is an antifibrinolytic medication used to reduce bleeding in a variety of medical settings. The use of TXA in total hip arthroplasty (THA) and total knee arthroplasty (TKA) has resulted in dramatic decreases in operative blood loss and transfusion rates, revolutionizing the field of arthroplasty. The use of TXA, now common, has made autologous blood donation programs largely obsolete. Additionally, it has made perioperative blood transfusion uncommon.
While AAOS guidelines suggest that all three available preparations of TXA (oral, IV, topical) are effective, preferred route of dosing varies by provider and institution. These preferences are based on habit, understanding of pharmacodynamics, and logistical issues regarding effective dosing. Oral TXA is the cheapest option, but some surgeons prefer IV dosing due to concerns regarding efficacy and controlled dosing.
In this study, we seek to compare the efficacy of a single pre-op oral dose of TXA to a single pre-op IV dose of TXA.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients undergoing total hip arthroplasty (THA) through a posterior approach
- •Patients undergoing total knee arthroplasty (TKA)
- •Patients between 18-80 years of age
排除标准
- •Patients with >80 years of age
- •Patients with a BMI over 40
- •Patients undergoing general anesthesia
- •Patients with a history of major ipsilateral joint surgery
- •Patients on pre-operative anticoagulation or anti-platelet drugs (other than aspirin)
- •Patients with a history of bleeding disorders
- •Patients with platelets less than 100/nl
- •Patients with new-onset/active atrial fibrillation
- •Patients with a history of myocardial infarction in the past year
- •Patients with a history of a stroke in the past year
研究组 & 干预措施
Oral Tranexamic Acid (TXA)
100 Total Hip Arthroplasty (THA) and 100 Total Knee Arthroplasty (TKA) patients will be randomized to receive 1950 mg of oral TXA in the pre-operative area.
干预措施: Tranexamic Acid (Drug)
Intravenous (IV) Tranexamic Acid (TXA)
100 Total Hip Arthroplasty (THA) and 100 Total Knee Arthroplasty (TKA) patients will be randomized to receive 1 g of intravenous (IV) TXA upon transfer to the operating room.
干预措施: Tranexamic Acid (Drug)
结局指标
主要结局
Calculated Blood Loss
时间窗: post-operative day 0
Calculated Blood loss (CBL) measured in mL, measured at baseline (before surgery) and in the post-operative care unit (after surgery). The following formula was used CBL = BV × (HctPre - HctPost), where BV = (k1 × H3) + (k2 × W) + k3. The variables for the formula are as followed: CBL: Calculated blood loss BV: Blood volume at baseline HctPre: Haematocrit before surgery HctPost: Haematocrit after surgery H: Patient height in meters W: Patient weight in kilograms Although measured at two time points (before and after surgery), the calculated value from those two time points is average across all participants and reported.
次要结局
- Time to Discharge From Physical Therapy(From 48-72 hours after surgery)
- Length of Stay(After surgery to the time discharged from hospital (estimated 48-72 hours after surgery))
- Transfusion During Hospital Stay(From Post-Operative Day 0 to Post-Operative Day 2)