Topical Tranexamic Acid (TXA) in Hip Fractures, A Double-Blind, Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Change in hemoglobin
研究概览
简要总结
Mechanisms by which to reduce exposure to allogeneic blood are of financial and clinical benefit in the hip fracture population. Tranexamic acid (TXA) is an inexpensive medication with low complication risk. Its use in the hip fracture population is unproven. The purpose of this study is to evaluate the efficacy and safety of topical tranexamic acid in reduction of peri-operative blood loss in hip fracture surgery.
详细描述
The results of this study may dramatically alter the manner in which surgeons manage hip fracture patients in Canada. The use of topical TXA in operatively-treated hip fracture patients has the potential to reduce perioperative blood loss and consequently reduce exposure to allogeneic blood transfusion. This will positively influence post-operative morbidity and mortality, while at the same time substantially reduce hospital length of stay and overall health care costs. The proposed study is felt to have minimal risk, and is a relatively inexpensive study.
Update: An interim analysis was completed in January 2018. The Data Safety Monitoring Committee reviewed the results and recommend the trial continue as planned.
The final data analysis is in process. The abstract will be uploaded upon completion.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All of the following criteria must be met to be eligible:
- •18 years of age or older
- •Diagnosis of hip fracture (Intracapsular, Intratrochanteric or Subtrochanteric) requiring surgical repair
- •Patient/surrogate decision maker provide signed informed consent
排除标准
- •Participants cannot be included in this study if any of the following criteria apply:
- •Patient has documented renal failure with glomerular filtration rate of <30ml/min/1.73m2
- •Documented allergy to tranexamic acid
- •Current use of hormone replacement therapy
- •Acquired disturbances of colour vision
- •Refusal of blood products
- •Pre-operative use of anticoagulant therapy (Coumadin, heparin < 5 days of surgery, fibrinolytic disorders requiring intraoperative anti-fibrinolytic treatment)
- •Coagulopathy (pre-operative platelet count <150,000/mm3, International Normalized Ratio (INR) >1.4, prolonged Partial Thromboplastin Time (PTT) >1.4x normal)
- •Acute coronary syndrome within 6 weeks of fracture
- •Any history of venous thromboembolism
- •Any intraoperative surgical/medical/anesthetic complications i.e.: myocardial infarction or neurovascular injury occurring prior to application of the tranexamic acid
- •Pregnant or lactating
- •Any major medical or psychiatric disorder that in the opinion of the investigator, might prevent the subject from completely participating in the study or interfere with the interpretation of the study results
- •Unable/unwilling to provide informed consent
研究组 & 干预措施
Tranexamic Acid Wash
Participants in the experimental arm will receive a wash of tranexamic acid topically at the site of surgery.
干预措施: Tranexamic Acid (Drug)
Saline Wash
Participants in the control arm will receive a wash of saline topically at the site of surgery.
干预措施: Saline Wash (Other)
结局指标
主要结局
Change in hemoglobin
时间窗: 1 day and 3 days post-surgery
change in hemoglobin levels day 1 and 3 post-op compared to pre-op values and need for allogenic blood transfusion up to 3 days post-op
次要结局
- All-cause mortality(30 days post-surgery)
- Reduced risk of thrombotic event(30 days post-surgery)
- Reduced peri-operative complications(30 days post-surgery)