Weighted Versus Uniform Dose of Tranexamic Acid in Patients Undergoing Primary, Knee Arthroplasty, a Randomized-clinical Trial.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Primary Intra-operative Blood Loss
研究概览
简要总结
Hypotheses: Primary - A weighted dose of 20 mg/kg of tranexamic acid will be more efficacious than a single uniform dose of 1 gram in primary total knee arthroplasty (TKA) cases. This includes having a greater impact on decreasing blood loss without increasing the occurrence of adverse thromboembolic events in patients undergoing primary, elective total knee arthroplasty.
Secondary - TA will decrease blood loss more effectively in women than in men undergoing this procedure.
详细描述
Overall Study Design
Study design and control methods:
This study is designed as a prospective, randomized, double-blinded controlled clinical trial to compare the effect of a single uniform 1 g dose of TA and a single weighted 20 mg/kg dose of tranexamic acid (TA).
Treatment group:
The subjects will be randomly assigned to the uniform dose group or weighted dose group at the time of the surgery via the opening of a randomly selected closed envelope. The patient and the independent reviewer will be blinded as to the dose of TA utilized during the surgery. This information will be linked to a confidential database for later review by the principal investigator.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients must be male or female of any race
- •Ages 18-80 years old
- •Patients must be undergoing an elective, primary knee arthroplasty
- •Patients must be able to understand and willing to cooperate with study procedures
- •Patients must be able to provide written and verbal informed consent
排除标准
- •Allergy or intolerance to the study materials
- •History of a venous thromboembolic event being treated with life-long anticoagulation
- •Patients with a known congenital thrombophilia
- •Patients who have had a venous thromboembolic event within the 12 months preceding surgery
- •History of any substance abuse or dependence within the last 6 months
- •Failure in collecting a required data point during study
- •Those patients not indicated for knee replacement surgery including, pregnant women, those not cleared medically for the procedure and patients without significant radiographic evidence of degenerative joint disease.
- •Patient using autologous blood transfusion
研究组 & 干预措施
Females receiving a uniform dose of TA
Women receiving a single dose of 1 gram of TA--includes all women that will get 1 gram dose of the TA during surgery. Postop outcomes wil be measured for comparison, including hemoglobin, hematocrits and blood loss.
干预措施: Females receiving a uniform dose of TA (Drug)
Weighted dose of TA in female patients
Female patients receiving a weighted dose of TA. Will include all women that will get a weighted dose of the TA during surgery. Postop outcomes wil be measured for comparison, including hemoglobin, hematocrits and blood loss.
干预措施: Females Tranexamic Acid weighted dose (Drug)
Tranexamic acid weighted dose male
Male patients randomized to the weighted dose of TA. Postop outcomes wil be measured for comparison, including hemoglobin, hematocrits and blood loss.
干预措施: Males Weighted Dose TA (Drug)
Uniform single dose TA male patient
Male patients receiving a single dose (1gram) of TA during TKA. Includes all men that will get 1 gram dose of the TA during surgery. Postop outcomes wil be measured for comparison Postop outcomes wil be measured for comparison, including hemoglobin, hematocrits and blood loss. Patients will be randomized into one of these two groups.
干预措施: Tranexamic Acid standard dose (Drug)
结局指标
主要结局
Primary Intra-operative Blood Loss
时间窗: Intra-operative, an average of 3 hours
Record intra-operative blood loss through drain output
Document Incidences of DVT and Other Thromboembolic Events.
时间窗: 1 year
DVT = Deep Venous thrombosis Patients were assessed every 12 hours for development of pain within the lower extremity. Any reported muscle pain was evaluate with a bedside venous ultrasound by an ultrasound technician.
次要结局
未报告次要终点
研究者
Brett Levine, MD
Assistant Professor and Associate Residency Director
Rush University Medical Center