Postoperative Oral Tranexamic Acid in Patients Undergoing Primary Total Joint Arthroplasty
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- Visual Analog Score
研究概览
简要总结
The purpose of this study is to evaluate the impact of an extended oral Tranexamic Acid regimen on patient reported outcome scores, time to independent ambulation, postoperative range of motion, swelling, change in hemoglobin levels, 90-day complications, readmission and reoperation.
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
- Single (Participant)
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
- •Adults aged > 18 years (All women of childbearing potential undergo pregnancy testing prior to THA as per our institutional protocol)
- •Written informed consent
- •Patients undergoing primary THA diagnosis of end-stage osteoarthritis
- •Patients receiving spinal anesthesia
- •Patients being discharged on postoperative day 1
排除标准
- •Patients with a TXA allergy
- •Patients undergoing revision procedures
- •Patients undergoing primary THA for a diagnosis other than end-stage osteoarthritis
- •Patients receiving general anesthesia
- •Patients being discharged on the same day of surgery
- •Cancer patients
- •Patients with a history of prior VTE event
- •Patients on preoperative anticoagulants other than ASA
- •Pregnant patients (All women of child bearing potential undergo pregnancy testing prior to THA as per our institutional protocol)
- •Female patients who are on hormonal contraception
- •Patients with history of retinal vein or artery occlusion
研究组 & 干预措施
Oral tranexamic acid
干预措施: Oral Tranexamic Acid (Drug)
Control Group
结局指标
主要结局
Visual Analog Score
时间窗: Baseline, 3 days postoperative, 2 weeks, 6 weeks, 12 weeks
The VAS is a 11-item questionnaire assessing pain. Using a scale of 0 = no pain to 10 = worst pain. Total scores range from 0 - 110, lower scores indicating lower pain and higher scores indicating greater pain.
Hip Disability and Osteoarthritis Outcome Score (HOOS) for Joint Replacement (JR)
时间窗: Baseline, 3 days postoperative, 2 weeks, 6 weeks, 12 weeks
The Hip Disability and Osteoarthritis Outcome Score (HOOS) for Joint Replacement (JR) is a questionnaire designed to measure outcomes for patients with hip replacements. Results are scored 0-11. 0 = total hip disability, 100 = perfect hip health.
次要结局
- Hemoglobin(Baseline, prior to discharge, day 3 postoperatively)
- Harris Hip Score (HHS)(Baseline, 3 days postoperative, 2 weeks, 6 weeks, 12 weeks)
- Short Form Health Survey (SF-12)(Baseline, 3 days postoperative, 2 weeks, 6 weeks, 12 weeks)
- Time to Independent Ambulation(12 weeks)
- Oxford Hip Score(Baseline, 3 days postoperative, 2 weeks, 6 weeks, 12 weeks)
研究者
Joshua S. Bingham
Associate Professor of Orthopedics, Orthopedic Consultant
Mayo Clinic