Evaluating the Use of Tranexamic Acid (TXA) in Total Joint Arthroplasty
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Number of Participants Who Required a Blood Transfusion During Surgery
研究概览
简要总结
This research study aims to study the use of tranexamic acid (TXA) in total joint replacement (arthroplasty) of the hip (THR) and knee (TKR).
详细描述
Tranexamic Acid (TXA) is given to stop or reduce heavy bleeding. It works by stopping clots from breaking down and by decreasing unwanted bleeding. It is used in many types of surgeries to help reduce surgical complications such as blood loss and blood transfusions.
In orthopaedic surgeries, such as in total hip and knee replacements, TXA has been shown to effectively reduce blood loss and transfusion requirements without an increased risk of side effects such as deep venous thrombosis (DVT) or pulmonary embolism (PE). The ability to decrease blood loss is crucial, as other studies have shown that reducing blood loss decreases morbidity and mortality in patients.
Although, many TXA dosing regimens have been studied - all of which have been useful at reducing blood loss and decreasing transfusion requirements - the best TXA dosing regimen and the most cost-effective method of TXA administration for patients have yet to be determined. Moreover, a thorough and rigorous study on the use and effects of topical and intravenous TXA and the effect of TXA on patient outcomes has yet to be conducted.
Therefore, this research study aims to address those concerns in order to understand how best to use TXA to reduce surgical complications in patients undergoing total joint replacements.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Intravenous Tranexamic Acid
- 1g TXA administered intravenous piggyback at start of surgery OR
- 1g TXA administered intravenous piggyback at start and at time of closure of surgery
干预措施: Intravenous Tranexamic Acid (Drug)
Intravenous Placebo
- IV 0.9% sterile saline
干预措施: Intravenous Placebo (Drug)
Intravenous Tranexamic Acid followed by Intravenous Placebo
- 1g TXA administered intravenous piggyback at start of surgery OR
- 1g TXA administered intravenous piggyback at start and at time of closure of surgery
- IV 0.9% sterile saline
干预措施: Intravenous Placebo (Drug)
Intravenous Tranexamic Acid followed by Intravenous Placebo
- 1g TXA administered intravenous piggyback at start of surgery OR
- 1g TXA administered intravenous piggyback at start and at time of closure of surgery
- IV 0.9% sterile saline
干预措施: Intravenous Tranexamic Acid (Drug)
结局指标
主要结局
Number of Participants Who Required a Blood Transfusion During Surgery
时间窗: operative period (average of 1 hour)
Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.
次要结局
- Walking Distance Post Total Joint Arthroplasty of the Hip(4 Days)
- Length of Hospital Stay(At Hospital Discharge)
- Change in Levels of Hematocrit: Pre-operative to Post-operative(Day 3 or 4 post surgery)
- Estimated Blood Loss During Surgery(Operative period (an average of 1 hour))
- Change in Hemoglobin: Pre-operative to Post-operative(Day 3 or 4 post surgery)