Assessing the Efficacy of Tranexamic Acid (TXA) in Hip Arthroscopy: A Randomized, Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Visual clarity grade
研究概览
简要总结
The primary goal of this study will be to determine if perioperative IV Tranexamic Acid (TXA) administration will reduce intra-operative bleeding and subsequently improve visual clarity during surgery and reduce operative traction time in patients undergoing hip arthroscopy. Additionally, this study aims to determine whether IV TXA injections will reduce post-operative pain and affect hip-specific patient-reported outcomes in patients undergoing hip arthroscopy.
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 or older
- •Scheduled to undergo primary hip arthroscopy for any intra-articular procedure
- •Able to complete and understand study materials in English
排除标准
- •Age under 18 years
- •Cannot complete and understand study materials in English
- •Patients undergoing revision surgery
- •Patients who have had previous surgery to the study joint
- •Patients on drugs that interfere with coagulation or TXA clearance
- •Patients with a known allergy to TXA
- •Patients with any of the following comorbidities
- •Bleeding and/or coagulative disorders
- •Renal impairment
- •Sickle cell disease
- •Thrombotic diseases
- •Comorbidities preventing surgery (including pregnancy)
研究组 & 干预措施
Tranexamic Acid
Patients will be injected with 15 mg/kg of tranexamic acid in 100mL of normal saline via IV access normally established for this procedure.
干预措施: Tranexamic acid (Drug)
Placebo
Patients will be injected with 100mL of normal saline via IV access normally established for this procedure.
干预措施: Placebo (Drug)
结局指标
主要结局
Visual clarity grade
时间窗: Throughout surgical procedure
Surgeon-Reported Visual Clarity Grade Grade 1: Active bleeding leading to poor visibility Grade 2: Moderate amount of blood mixed with the irrigation fluid, where the visibility is slightly affected but is acceptable for operating Grade 3: Little or no bleeding; the visibility is excellent to perform the operation
次要结局
- Intra-operative Visibility Score(Throughout surgical procedure)
- Visual Analog Scale (VAS) Pain Score(Pre-operative baseline up through 24 weeks after surgery)
- International Hip Outcome Tool 12 (iHOT)(Pre-operative baseline up through 24 weeks after surgery)
- Estimated blood loss(Throughout surgical procedure)
- Post-operative dressing changes(From time of surgery completion through 2 weeks post-op)
- Thromboembolic events(From surgery start time through first 6 months post-op)
- modified Harris Hip Score (mHHS)(Pre-operative baseline up through 24 weeks after surgery)
- Operative traction time(Throughout surgical procedure)
- Complications(From surgery start time through first 6 months post-op)
研究者
Vehniah Tjong
Assistant Professor
Northwestern University