Extended Post-operative Oral TXA vs.Standard Perioperative TXA in Primary TJA: A Randomized, Double-Blind, Placebo-Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 170
- 主要终点
- 6-week KOOS JR (TKA) or HOOS JR (THA) score
研究概览
简要总结
The goal of this clinical trial is to learn if extended post-operative oral tranexamic acid (TXA) - a medication that reduces bleeding by slowing the breakdown of blood clots - can improve functional recovery following surgery in adults undergoing primary total knee or hip arthroplasty for osteoarthritis. The main question it aims to answer is: Does extended post-operative oral TXA improve functional outcomes at 6 weeks post-operatively compared to standard perioperative TXA alone? Researchers will compare patients receiving extended oral TXA to patients receiving matching placebo capsules on the same schedule to see if the extended TXA regimen reduces blood loss, improves early functional outcomes, and reduces pain without increasing complication rates. Participants will receive standard perioperative oral TXA (1.95 g) prior to surgical incision, along with standard VTE prophylaxis. They will be randomly assigned to receive either oral TXA or matching placebo capsules once daily on post-operative days 1, 2, and 3. Participants will attend follow-up visits at 2, 6, and 12 weeks post-operatively to complete functional outcome questionnaires, pain assessments, and - for knee replacement patients - range of motion measurements.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Age ≥18 years
- •Undergoing primary total knee arthroplasty (TKA) or total hip arthroplasty (THA) for osteoarthritis
- •Ability to provide written informed consent
- •Willingness to comply with study protocol
排除标准
- •History of venous thromboembolism (DVT or PE)
- •Active malignancy
- •Allergy or contraindication to tranexamic acid (TXA)
- •Post-operative anticoagulation therapy other than aspirin
- •History of color blindness or retinal disease
研究组 & 干预措施
Placebo
Patients will receive standard pre-operative 1.95mg oral TXA, followed by a placebo pill on post-operative days 1, 2 and 3.
干预措施: Placebo (Drug)
Extended Oral TXA
Participants will receive standard 1.95mg pre-operative oral TXA dose in addition to 1.95mg oral TXA on post-operative days 1, 2, and 3.
干预措施: Extended oral tranexamic acid regimen (Drug)
结局指标
主要结局
6-week KOOS JR (TKA) or HOOS JR (THA) score
时间窗: At 6 weeks from timing of surgical intervention
Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR) for patients undergoing Total Knee Arthroplasty or Hip injury and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR) for patients undergoing Total Hip Arthroplasty at 6 weeks post-operatively.
6-week Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR) or Hip injury and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR) score
时间窗: At 6 weeks from timing of surgical intervention
Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR) for patients undergoing Total Knee Arthroplasty or Hip injury and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR) for patients undergoing Total Hip Arthroplasty at 6 weeks post-operatively. Scale for booth outcome scores is 0 to 100, with a higher score representing improved patient-reported knee or hip health.
次要结局
- 2-week KOOS JR (TKA) or HOOS JR (THA) score(At 2 weeks from timing of surgical intervention)
- 12-week KOOS JR (TKA) or HOOS JR (THA) score(At 12 weeks from timing of surgical intervention)
- 2-week VAS pain score(At 2 weeks from timing of surgical intervention)
- 6-week VAS pain score(At 6 weeks from timing of surgical intervention)
- 12-week VAS pain score(At 12 weeks from timing of surgical intervention)
- 6-week absolute knee flexion(At 6 weeks from timing of surgical intervention)
- Transfusion rate(From enrollment to end of treatment at 12 weeks from timing of surgical intervention)
- Blood product units transfused(From enrollment to end of treatment at 12 weeks from timing of surgical intervention)
- Incidence of Symptomatic DVT(From enrollment to end of treatment at 90 days from timing of surgical intervention)
- Incidence of Symptomatic PE(From enrollment to end of treatment at 90 days from timing of surgical intervention)
- Incidence of Acute Coronary Sndrome(From enrollment to end of treatment at 90 days from timing of surgical intervention)
- Incidence of Cerebrovascular Accident(From enrollment to end of treatment at 90 days from timing of surgical intervention)
- Rate of Readmission(From enrollment to end of treatment at 12 weeks from timing of surgical intervention)
- Rate of Reoperation(From enrollment to end of treatment at 90 days from timing of surgical intervention)
- All-cause Mortality Rate(From enrollment to end of treatment at 90 days from timing of surgical intervention)
- 2-week Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR) or Hip injury and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR) score(At 2 weeks from timing of surgical intervention)
- 12-week Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR) or Hip injury and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR) score(At 12 weeks from timing of surgical intervention)
- 2-week Visual Analog Scale (VAS) pain score(At 2 weeks from timing of surgical intervention)
- 6-week Visual Analog Scale (VAS) pain score(At 6 weeks from timing of surgical intervention)
- 12-week Visual Analog Scale (VAS) pain score(At 12 weeks from timing of surgical intervention)
研究者
Ryland Kagan
Associate Professor of Orthopaedics and Rehabilitation
Oregon Health and Science University