Reinfusion Drains vs Tranexamic Acid in Total Joint Arthroplasty
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 204
- 试验地点
- 2
- 主要终点
- Blood Transfusion
研究概览
简要总结
It is widely reported that a large percentage of total joint replacement patients receive allogeneic (human donor blood) blood transfusions due to perioperative blood loss with numbers ranging from 30% to 80%.
The risks of allogenic blood transfusion are well documented in the literature. In addition, they are time-consuming: often lengthening hospital stay and decreasing the availability for postoperative physical therapy. Moreover, they are costly at several hundred dollars per unit, and allogeneic transfusions are linked with immunosuppression and increased postoperative infection rates and wound healing problems, which are devastating complications in this elective, joint replacement population. Several options are available for diminishing the need for allogenic blood transfusion following elective total joint replacement. These include the use of perioperative blood salvage devices (OrthoPAT) and tranexamic acid. While there is data to support the use of both OrthoPat and Tranexamic acid in primary total joint arthroplasty, there is little information comparing one versus the other in terms of efficacy and economics.
The purpose of this study is to compare the safety, effectiveness and cost benefit of Hemovac drain, OrthoPAT and Tranexamic Acid to manage blood loss during total hip and total knee replacement surgery.
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
- None
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
- •Patients presenting for primary unilateral hip or knee arthroplasty
- •> 18 years of age
- •Preoperative hemoglobin on day of surgery > 10mg/dL
排除标准
- •Patients with a preoperative Hgb < 10mg/dL
- •Patients who are unwilling to consent to blood transfusions
- •Patients with a history of bleeding disorder
- •Patients on anticoagulation therapy preoperatively (ASA 325mg, Plavix or Coumadin)
- •Patients with a history of Thromboembolic events ( DVT, PE, CVA MI)
- •Patients with platelet counts < 100,000
- •Patients with kidney disease (Serum Cr > 1.2)
- •Patients with end stage renal disease or on hemodialysis
- •Patients with renal transplant
- •Patients presenting for bilateral total hip or knee arthroplasty
- •Patients presenting for conversion or revision total hip or knee procedures
- •Patients donating pre-autologous blood
- •Patients with primary hematologic disease or malignancy
- •Patients with allergy to Tranexamic Acid
- •Patients with hepatic disease
- •Patients not discontinuing steroid use prior to surgery
- •Patients with religious beliefs/practices prohibiting blood transfusions
- •Patients with cognitive impairment
- •Patients who are terminally ill
结局指标
主要结局
Blood Transfusion
时间窗: Inpatient Postoperative, on average 3 days after surgery
Transfusion Rate (i.e, number of participants needing Blood Transfusion) Between Treatment Groups
Change in Hemoglobin Level
时间窗: Post-operative on day 2 (first day after surgery)
Change in hemoglobin following surgery. Initial (baseline) measure was prior to surgery on day of surgery. Follow-up measurement occurred the day following surgery.
次要结局
未报告次要终点