Investigation of the Blood Sparing Properties of Intravenous Tranexamic Acid With Anatomic and Reverse Total Shoulder Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Post-operative Blood Loss
研究概览
简要总结
To compare intravenous Tranexamic Acid (TXA) versus normal saline placebo to determine whether or not TXA administration reduces blood loss, decrease in hemoglobin, and rate of transfusions following anatomic and reverse total shoulder arthroplasty (TSA) surgeries.
详细描述
Anatomic and reverse total shoulder arthroplasty (TSA) is associated with the risk of moderate to significant blood loss that can lead to transfusions. Average estimated blood loss has been reported in the range of 354 to 361 mL intraoperatively, not accounting for additional postoperative blood loss postoperatively in surgical drains. Transfusion rates have been reported to range from 2.4% to 9.5% in recent studies, with rates over 30% for revision cases. Tranexamic acid (TXA) is a synthetic antifibrinolytic agent that is an established method of reducing blood loss and transfusion requirement for patients undergoing total hip and knee arthroplasty. TXA can be administered intravenously, topically (intraarticularly), or orally, with most available literature addressing intravenous and topical administration. Systematic reviews and meta-analyses of the total hip and knee arthroplasty literature demonstrate approximately a 30% decrease in blood loss and 50% decrease in transfusion rate with topical or intravenous administration of TXA compared to placebo. Moreover, the literature demonstrates no increased rate of thromboembolic or other complications associated with TXA administration for hip and knee arthroplasty.
Despite proven efficacy in the hip and knee arthroplasty literature, there have been no studies analyzing the ability of TXA to reduce blood loss and transfusion rate following TSA.
Purpose of the study is to compare intravenous Tranexamic Acid (TXA) versus normal saline placebo to determine whether or not TXA administration reduces blood loss, decrease in hemoglobin, and rate of transfusions following anatomic and reverse total shoulder arthroplasty (TSA) surgeries. With the hypothesis that intravenous TXA will reduce blood loss following TSA.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Any patient scheduled for a primary anatomic or reverse TSA
排除标准
- •Allergy to TXA
- •Acquired disturbances of color vision
- •Pre-op use of anticoagulant therapy within five days before surgery
- •History of arterial or venous thromboembolic disease; such as DVT, PE, CVA, TIA
- •Pregnancy or breastfeeding
- •Recent MI (within 6 months of surgery) or any placement of stent regardless of time since placement
- •Renal impairment
- •Refusal of blood products
- •Any patient undergoing a revision TSA
- •Patients who decline to participate
研究组 & 干预措施
Tranexamic Acid Group
Group will be administered 1 gram tranexamic acid IV bolus (10 ml solution) 10 minutes prior to incision.
干预措施: Tranexamic Acid (Drug)
Placebo Group
Group will be administered 10 ml normal saline placebo IV bolus 10 minutes prior to incision
干预措施: Placebo (Drug)
结局指标
主要结局
Post-operative Blood Loss
时间窗: Average of 3 days post-operatively
Equated based on the patient's predicted blood volume and change in hemoglobin from the pre-operative level to the lowest post-operative level.
次要结局
- Number of Units Transfused(Average of 3 days post-operatively)
- Number of Patients Transfused(Average of 3 days post-operatively)
- Number of Participants With Deep Vein Thrombosis(30 days post-operative)
- Number of Participants With Pulmonary Embolism(30 days post-operative)
- Number of Participants With Stroke(30 days post-operative)