Do Anesthesiologists Follow Guidelines on Perioperative Use of Tranexamic Acid?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,726
- 试验地点
- 1
- 主要终点
- Comparison of percentage use of TXA before and after the release of TXA recommendations
研究概览
简要总结
Tranexamic acid has been used to reduce bleeding and transfusion for years. Randomized studies showed its efficacity in orthopedic surgery, trauma and post-partum hemorrhage. Few data were available for other types of surgery and the safety profile of tranexamic use was nor clearly established. In april 2022, the results from the POISE-3 (Perioperative Ischemic Evaluation - 3) trial was published in the New England Journal of Medicine. This stdy clearly demonstrated in 9535 patients undergoing non-cardiac surgery, that the use of tranexamic acid significantly reduced not only perioperative bleeding, but also transfusions. The safety profile of tranexamic acid was very good in this trial. This publication was rapidly followed by editorials in major anesthesia journals, calling for "safe surgery" with a systematic use of tranexamic acid in the population studied in the POISE-3 trial. A literature review was done with a formal presentation at Erasme University Hospital, again with the call for a systematic use in appropriate patients.
In this study, the adherence to these recommendations will be tested. All patients operated between october 1st 2022 and december 31 st 2022 will be included. For every patient, it will be determined if this patient should have received tranexamic acid according to the results of the POISE-3 trial and wether this patient really did get tranexamic acid. Primary endpoint will be the percentage (%) of patients correctly treated according to the POISE-3 recommendations. A second primary endpoint will be the comparison with patients operated between October 1st 2021 and december 31st 2021; that means before the publication of the recommendations. The difference between both populations will be tested with a Chi-square test. Secondary outcomes wil be bleeding and transfusion in the correctly treated population compared with an eventually not correctly treated population.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Patients undergoing surgery either between oct 1st 2021 and dec 31st 201 or oct 1st 2022 and dec 31st 2022
- •noncardiac surgery
- •expected to require at least one overnight hospital admission after surgery
- •at risk of perioperative bleeding
排除标准
- •cardiac surgery
- •intracranial neurosurgery
- •creatinine clearance < 30 mL/min (Cockcroft-Gault equation)
- •chronic dialysis
- •history of seizure disorder
- •recent (< 3 months) stroke, myocardial infarction, acute arterial thrombosis, venous thromboembolism
- •fibrinolytic condition following consumption coagulopathy
- •subarachnoid hemorrhage within 30 days before surgery
- •women of childbearing potential who are not taking effective contraception, pregnant or breast-feeding
研究组 & 干预措施
Before TXA recommendations
All patients operated between october 1st, 2021 and december 31st 2021, that means before the publication of the POISE-3 trial and the recommendations on the use of tranexamic acid.
干预措施: Use of tranexamic acid (Drug)
After TXA recommendations
All patients operated between october 1st, 2022 and december 31st 2022, that means after the publication of the POISE-3 trial and the recommendations on the use of tranexamic acid.
干预措施: Use of tranexamic acid (Drug)
结局指标
主要结局
Comparison of percentage use of TXA before and after the release of TXA recommendations
时间窗: 12 hours
The use of tranexamic acid (in percentage) will be compared between the two cohorts, before and after the publication of the recommendations on the use of tranexamic acid
Percentage of correct use of TXA
时间窗: 12 hours
Percentage of patients who received tranexamic acid correctly according to the POISE-3 criteria
次要结局
- Transfusion(24 hours)
- Blood loss(24 hours)
