Prolonged Oral Tranexamic Acid Use in Primary Total Joint Arthroplasty: A Double Blind Randomized Placebo Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 351
- 主要终点
- Primary endpoint: knee range of motion
研究概览
简要总结
This is a prospective, double-blind, randomized controlled trial evaluating the efficacy of oral tranexamic acid (TXA) in total knee arthroplasty (TKA). The study will assess pain, function, and range of motion (ROM) over a 2-year period, with key evaluations at 6 weeks and 90 days postoperatively.
Hypothesis:
Patients receiving 1.95g oral TXA for 3 or 7 days post-op will show improved pain, function, and ROM at 6 weeks and 90 days, with similar blood loss and transfusion rates as the control group.
详细描述
OBJECTIVES:
Purpose:
This is a prospective, double-blinded, randomized control study to evaluate the efficacy and role of oral Tranexamic acid in total knee arthroplasty by assessing pain, function, and range of motion over a 2-year follow-up period.
Hypothesis:
We hypothesize that those given 1.95g oral TXA for 3- and 7-days post-op will have improved pain, function, and range of motion assessed at the 6-week follow-up along with improved range of motion (ROM) at the 90-day follow-up. Additionally, we expect both the control group and the experimental group to have similar blood loss and 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
- Triple (Participant, Care Provider, 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
- •Any patient undergoing primary TKA at Rush main hospital or participating ASC
- •Willingness to undergo randomization to take medication potentially up to 7 days post op.
- •Willing to answer daily questions on pain, functionality and opioid consumption
排除标准
- •History of venous thromboembolism, MI, or stroke in the past year
- •Patients on any chronic anticoagulation medications besides Aspirin
- •Patients with Cancer
- •Patients with end stage renal disease that are on dialysis
- •Drug allergy to TXA
- •Taking oral birth control
- •Unable to provide consent
研究组 & 干预措施
Oral-Long Arm
1.95g TXA daily for post operative days 1-7
干预措施: tranexamic acid Oral-Long Arm (Drug)
Oral-Short Arm: 1.95g TXA daily POD 1-3
1.95g TXA daily for post operative days 1-3
干预措施: tranexamic acid Oral-Short Arm (Drug)
Control Group: Placebo for 3 days post-op
Placebo for 3 days post-op
干预措施: Control group placebo (Drug)
结局指标
主要结局
Primary endpoint: knee range of motion
时间窗: (flexion/extension) at 2 weeks and 6 weeks post op
Primary Endpoint: Knee ROM
次要结局
- Secondary" VAS pain scores(2 weeks, 6 weeks, and 3 months post op)
- Secondary: KOOS Jr(2 weeks. 6 weeks, 3 months post op)
- secondary: EQ-5D-3L functional scores(2 weeks, 6 weeks, and 3 months post op)
- Adverse events and complications(3 months post op)
研究者
Bailey Terhune
Principle Investigator
Rush University Medical Center