Randomized Controlled Trial of Tranexamic Acid in Total Knee Arthroplasty: Intravenous vs. Topical
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 640
- 试验地点
- 2
- 主要终点
- Total Blood Loss
研究概览
简要总结
The purpose of this study is to determine whether topical or intravenous administration of tranexamic acid during unilateral total knee replacement is more effective at reducing bleeding in the first 24 hours following surgery. Tranexamic acid is a synthetic drug that has been shown to reduce blood drain output and the need for blood transfusions in both its topical and intravenous forms and is commonly used in orthopedic surgery. We hypothesize that IV and topical administration of tranexamic acid will be equally good at reducing the loss of blood and the need for transfusion immediately following total knee replacement.
详细描述
This randomized controlled trial compares the blood loss of patients undergoing unilateral total knee replacements who randomly receive either the topical or the intravenous form of tranexmamic acid during surgery. Patients in the intravenous arm of the study will receive 1 gram of tranexamic acid in 10 milliliters of solution prior to inflation of the tourniquet and 1 gram of tranexamic acid in 10 milliliters of solution during closure. For patients in the topical arm of the study, prior to the release of the tourniquet they will receive 3 grams of tranexamic acid in 75ccs of solution directly on the site of the incision.
The primary result measurement will be blood drain output from the knee at 24 hours after surgery.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary total knee replacmeent
- •Osteoarthritis
- •Unilateral
排除标准
- •Revision surgery
- •Donated preoperative autologous blood
- •On chronic anticoagulation medication such as Coumadin, Xarelto, Plavix, or Aspirin (other than 81mg)
- •Preoperative hepatic or renal dysfunction
- •Diagnosis of inflammatory disease
- •Diagnosis of inflammatory arthritis
- •Breastfeeding
- •Preoperative hemoglobin <10g/dL
- •International Normalized Ratio>1.4
- •Abnormal Partial Thromboplastin Time
- •Preoperative platelet count of <150,000mm^3
- •Creatinine > 1.4
研究组 & 干预措施
Topical Tranexamic Acid
3 vials of tranexamic acid (1g tranexamic acid in 10cc each) must be mixed in the operating room by the team at the start of surgery with 45cc of saline solution (for a total of 3g tranexamic acid in 75mL solution). This solution will be applied to the open joint surfaces with two 60mL syringes (one with 60mL and one with 15m). The solution will be left in contact with the tissues for five minutes. The surgeon will suction away excess solution. The site may be irrigated before or after the tranexamic acid bath as long as the solution is in contact for at least five full minutes. After that, the tourniquet will be released and the rest of the surgery will proceed according to the standard of care.
干预措施: Topical Tranexamic Acid (Drug)
Intravenous Tranexamic Acid
1 vial (1g of IV tranexamic acid in 10mL solution) will be administered prior to inflation of the tourniquet. A second 1g dose of IV tranexamic acid will be given during initiation of the closure after the tourniquet is deflated and during closure.
干预措施: Intravenous Tranexamic Acid (Drug)
结局指标
主要结局
Total Blood Loss
时间窗: during surgery
The amount of blood lost during surgery is the primary outcome measure. Blood loss is determineusing an equation that calculates the patient's blood volume based on their height and weight, then multiplies the patient's blood volume by the change in their hematocrit after surgery compared to before surgery.
次要结局
- The Number Patients Requiring a Transfusion(over course of hospital stay (averaging three days))
- Drain Output(from end of surgery to 24 hours postoperatively)