Efficacy of Tranexamic Acid in Foot and Ankle Surgeries- a Randomized Controlled Trial.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Total Estimated Blood Loss
研究概览
简要总结
Epidemiology of foot and ankle surgeries that present to the hospitals in the US are often underestimated. However there has been growing emphasis on identification of these injuries and practice patterns.
详细描述
Approximately 20% of all foot and ankle fractures are open. Excellent operative field without measurable bleeding remain prerequisite of most orthopedic procedures. Increase blood loss can increase the risk of infection, hematoma formation and wound complications. Presence of blood in synovium not only has direct corrosive effects but also causes increased intra capsular pressure leading to capsular fibrosis culminating as ankyloses.
Tourniquets are employed to optimize surgical field visualization thereby limiting operative duration and improving technical precision. There are several unwanted effects that can arise from use of tourniquet like neurapraxia, vascular injury, post operative swelling etc. Hence there is a growing interest in achieving the same operative goals without the use of tourniquet.
Antifibrinolytics come to one's rescue to achieve a blood sparing effect. Its efficacy in reducing intra operative and post operative blood loss is well documented in cardiac surgery, hip and knee replacement surgery and spinal surgery. Tranexamic acid is a synthetic antifibrinolytic drug that competitively blocks the lysine-binding sites of plasminogen, plasmin and tissue plasminogen activator, thereby delaying fibrinolysis and blood clot degradation. It has been effectively used as IV, oral, topical as well as intra articular dosing. The effects of IV administration lasts 8-17 hours after the initial dose. Orthopedic surgeons have incorporated TXA into multiple elective surgeries as a means of reducing blood loss and transfusion requirements. Reduced bleeding translates to decreased incidence of wound hematoma and other complications.
Effectiveness of Tranexamic acid(TXA) is unknown in foot and ankle surgeries. The aim of this study is to not only evaluate effectiveness of intravenous TXA in reducing post operative blood loss during foot and ankle surgeries but also if it modulates to reduced wound complications and reduced narcotic consumption.
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
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ASA (American Society of Anesthesiology) class I-IV
- •age 8-75.
排除标准
- •ASA class V
- •morbid obesity
- •patient refusal
- •patients with known coagulopathy disorder
- •renal insufficiency
- •hepatic dysfunction
- •serious cardiac disease
- •an allergy to TXA or receiving antiplatelet and /or anticoagulant drugs will be excluded.
研究组 & 干预措施
Tranexamic acid group
10mg/kg intravenous tranexamic
干预措施: Tranexamic Acid (Drug)
Normal Saline group
10mg/kg intravenous normal saline
干预措施: Normal saline (Drug)
结局指标
主要结局
Total Estimated Blood Loss
时间窗: Average intra operative time 1-2 hours
Total estimated blood loss in millilitres during the surgery
次要结局
- Number of Participants With Wound Complications(at first post-operative visit, 2 weeks post surgery)
- Intra Operative Narcotic Consumption(Average intra operative time 1-2 hours)
- Post Operative Narcotic Consumption(2 weeks after surgery)
研究者
Yan Lai
Assistant Professor
Icahn School of Medicine at Mount Sinai