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临床试验/NCT05783648
NCT05783648已完成不适用

Do Anesthesiologists Follow Guidelines on Perioperative Use of Tranexamic Acid?

Erasme University Hospital1 个研究点 分布在 1 个国家目标入组 1,726 人开始时间: 2023年7月3日最近更新:
适应症
干预措施
相关药物

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

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)

研究者

发起方
Erasme University Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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