Non-inferiority Trial of Oral Tranexamic Acid (OTA) vs. Intravenous Tranexamic Acid (IVTA) to Prevent Blood Loss in Joint Replacement Surgery
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- Lower number of units of blood required for transfusion.
研究概览
简要总结
The purpose of this research is to determine if the oral form of a medication (tranexamic acid) to reduce bleeding can be used in place of an intravenous (IV) form, to learn the best way to give tranexamic acid: either a pill by mouth, or a solution by vein.
详细描述
The purpose of this research is to determine if the oral form of a medication (tranexamic acid) to reduce bleeding can be used in place of an intravenous (IV) form.to learn the best way to give tranexamic acid: either a pill by mouth, or a solution by vein. Tranexamic acid is a medicine that reduces blood loss and reduces the need for blood transfusions in surgery. This drug is not experimental and has been used widely to treat patients in many settings, including orthopedic procedures, to reduce bleeding. This medication is now part of the standard of care at many centers in the U.S. and around the world. Orthopedic procedures have used iv tranexamic acid more often, but there are reasons to believe that the oral form may be at least equivalent and perhaps better at lower cost to the health care system. No other study has yet performed a systematic comparison to answer the question.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •To be included into this study, you must be undergoing hip or bilateral knee replacement surgery.
- •You must be healthy enough to undergo joint replacement surgery.
- •You must be able to understand and sign an informed consent.
- •You must be at least 18 years of age.
排除标准
- •You cannot be under 18 years of age.
- •You cannot be undergoing revision hip or revision bilateral knee replacement surgery.
- •You cannot be part of this study if you are allergic to the medication
- •You cannot participate if you are on hemodialysis,
- •You cannot participate if you have active coronary artery disease and if you have various vascular stents in place.
- •You will also be excluded if you have ever had a blood clot (deep vein thrombosis (DVT), pulmonary embolism (PE)).
- •You will also be excluded if you have ever had a cerebral or subarachnoid hemorrhage (brain bleeding), or stroke (cerebral vascular accident or transient ischemic attack).
- •If you are on estrogen-containing medication (hormone replacement therapy or oral contraceptive) within 7 days of surgery, you cannot take part in this study.
研究组 & 干预措施
Oral Tranexamic Acid (OTA)
Subjects will be randomized 1:1 to receive either IVTA or OTA with corresponding placebos. OTA will be given as 1950 mg 1-2 hours prior to OR and 1950 mg 2 hours after surgical close, before discharge from PACU.
干预措施: Tranexamic Acid (Oral) (Drug)
Intravenous Tranexamic Acid (IVTA)
Subjects will be randomized 1:1 to receive either IVTA or OTA with corresponding placebos. IVTA will be given as 1 g intravenously at time of first incision (THA or bTKA without tourniquet) or just before 1st tourniquet application (bTKA), and then again, 1 g after final surgery closure.
干预措施: Tranexamic Acid (Intravenous) (Drug)
结局指标
主要结局
Lower number of units of blood required for transfusion.
时间窗: 2 Years
Lower number of units of blood required for transfusion in the OR and post-operatively, hospital-wide.
次要结局
- Length of Stay(1-3 Days)
- Lower incidences of patients requiring blood transfusion.(2 Years)
- Lower Blood Loss in Patients(Hospital Stay: 1-3 days.)
研究者
Kenneth Bauer
Principal Investigator
The New England Baptist Hospital