Reducing Hemarthrosis in Anterior Cruciate Ligament Reconstruction With BTB Autograft by the Administration of Intravenous Tranexamic Acid: A Double-Blind Randomized Control Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- POST-OPERATIVE HEMARTHROSIS
研究概览
简要总结
The purpose of the proposed study is to evaluate the effects of administering intravenous tranexamic acid (TXA) to patients undergoing anterior cruciate ligament (ACL) reconstruction with bone-patellar tendon-bone autograft to minimize hemarthrosis within the knee joint and post operative pain.
详细描述
The purpose of the proposed study is to evaluate the effects of administering intravenous tranexamic acid (TXA) to patients undergoing anterior cruciate ligament (ACL) reconstruction with bone-patellar tendon-bone autograft to minimize hemarthrosis within the knee joint and post operative pain. Patients received the standard arthroscopic ACL reconstruction with a BTB autograft and were randomized to either receiving or not receiving two individual doses of TXA intra-operatively or receive. The goal of the study is to determine and evaluate the effect of intra-operative TXA on post-operative hemarthrosis, pain reduction, and opioid consumption.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PATIENTS UNDERGOING AN ACL RECONSTRUCTION WITH BTB AUTOGRAFT
排除标准
- •Legally incompetent or mentally impaired (e.g., minors, Alzheimer's subjects, dementia, etc.)
- •Younger than 18 years of age
- •Any patient considered a vulnerable subject
- •Have bleeding or clotting disorder
- •Preoperative anticoagulation therapy
- •Abnormal coagulation profile
- •Renal disorder or insufficiency
- •Sickle cell disease
研究组 & 干预措施
ACL Reconstruction w/ BTB Autograft + IV TXA
Patients receive a standard arthroscopic ACL reconstruction with a BTB autograft. In addition, these selected patients received two individual doses of intravenous TXA intra-operatively.
干预措施: Tranexamic Acid (Drug)
结局指标
主要结局
POST-OPERATIVE HEMARTHROSIS
时间窗: Post-operative week 1
Measured by assessing the operative knee at the first post-operative visit for the need of joint aspiration.
POST-OPERATIVE Patient Reported Pain Score on the Visual Analog Scale (VAS)
时间窗: Post-operative day 7
Pain severity, measured by the Visual Analog Scale (VAS): a scale of 1-10, with 1 being the least amount of pain and 10 being the most amount of pain.
POST-OPERATIVE Opioid Consumption
时间窗: Days 1-7
Each patient's opioid consumption was measured by morphine milligram equivalents (MME).
次要结局
未报告次要终点