The Role of Tranexamic Acid in Reducing Post Operative Hand Edema After Hand and Wrist Surgery (THAW): A Prospective, Randomized Controlled, Double-Blinded Pilot Study
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Treatment Completion Rate
研究概览
简要总结
Hand edema following hand surgery is a common yet devastating side effect that can lead to early stiffness, prolonged rehabilitation and diminished function. These factors can reduce a patient's quality of life; mounting to an overall delay in recovery, return to work and daily activities. Conventional edema therapy includes cryotherapy, external compression, active and passive exercises and various types of massage. However, there is little evidence to suggest these modalities are effective. Tranexamic acid (TXA) is an antifibrinolytic that has been used in surgical disciplines for decades to aid in reducing intraoperative blood loss and consequent transfusions. Recently, the use of TXA for curbing post-operative edema and ecchymosis has shown promising results, however, its use in hand surgery has not been studied.
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, Investigator)
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
- •All patients >18 years old undergoing distal radius fracture open reduction and internal fixation through a volar approach at St. Joseph's hospital in London, Ontario
- •All patients >18 years old undergoing open fasciectomy for Dupuytren's disease at St. Joseph's hospital in London, Ontario
排除标准
- •Revision surgery
- •Distal radius fractures treated with additive or alternative approaches and fixation to the volar approach
- •Known history of lymphedema or lymph node dissection on either upper extremity
- •Known allergic reaction to TXA
- •Cardiovascular problems (history of myocardial infraction, angina, and atrial fibrillation)
- •Cerebrovascular conditions (history of previous stroke)
- •Thromboembolic disorders (history of deep vein thrombosis [DVT] or pulmonary embolism [PE]), clotting disorders)
- •Known seizure disorder
- •Currently on dialysis
- •Current pregnancy or breastfeeding
- •Current use of hormone contraception
- •Unable to read consent and patient surveys related to the study in English
研究组 & 干预措施
Tranexamic Acid (TXA)
Patients in the TXA arm will receive 1 gram dose of intravenous (IV) tranexamic acid mixed with 50cc 0.9% sodium chloride before their surgery and 1 gram dose of intravenous (IV) tranexamic acid mixed with 50cc 0.9% sodium chloride 3-6 hours after the first dose on the day of their surgery
干预措施: Tranexamic acid (Drug)
Tranexamic Acid (TXA)
Patients in the TXA arm will receive 1 gram dose of intravenous (IV) tranexamic acid mixed with 50cc 0.9% sodium chloride before their surgery and 1 gram dose of intravenous (IV) tranexamic acid mixed with 50cc 0.9% sodium chloride 3-6 hours after the first dose on the day of their surgery
干预措施: Surgery (Procedure)
Standard of Care (SOC)
Patients in the (SOC) arm will receive 50cc of IV Placebo (standard intravenous normal saline fluid - 0.9% sodium chloride) before their surgery and 50cc of IV Placebo (standard intravenous normal saline fluid - 0.9% sodium chloride) 3-6 hours after the first dose on the day of their surgery
干预措施: Surgery (Procedure)
结局指标
主要结局
Treatment Completion Rate
时间窗: 12 weeks
Asses proportion of patients who correctly receive the intervention as per the protocol. The outcome goal will be 90%
Retention Rate
时间窗: 12 weeks
Proportion of participants to complete the study protocol and associated follow up. The outcome goal will be an 80% retention rate
Recruitment rate
时间窗: 12 weeks
Number of patients recruited to the study per month. The outcome goal will be 5 patients per month
Adherence to protocol
时间窗: 12 weeks
Assess number of patients who receive hand volume measurements at all designated time intervals. The outcome goal will be 90%
次要结局
- Patient-reported pain scores(12 weeks)
- Hand volume(12 weeks)
研究者
Ruby Grewal
Co-director of the clinical research lab within the Roth | McFarlane Hand and Upper Limb Center (HULC)
Lawson Health Research Institute