Do Anesthesiologists Follow Guidelines on Perioperative Use of Tranexamic Acid?

Study Overview
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Brief Summary
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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.

Official Title
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Do Anesthesiologists Follow Guidelines on Perioperative Use of Tranexamic Acid?

Conditions
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Tranexamic Acid, Blood Loss, Surgical, Blood Transfusion

Intervention / Treatment
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* Drug: Use of tranexamic acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Before TXA recommendations<br>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. | Drug: Use of tranexamic acid<br>* Percentage of correct use according to POISE-3 criteria of tranexamic acid<br>|
| After TXA recommendations<br>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. | Drug: Use of tranexamic acid<br>* Percentage of correct use according to POISE-3 criteria of tranexamic acid<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of correct use of TXA | Percentage of patients who received tranexamic acid correctly according to the POISE-3 criteria | 12 hours | 
| Comparison of percentage use of TXA before and after the release of TXA recommendations | 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 | 12 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood loss | Comparison of blood loss between correctly treated patients and not correctly treated patients according to the POISE-3 criteria | 24 hours | 
| Transfusion | Comparison of blood transfusion between correctly treated patients and not correctly treated patients according to the POISE-3 criteria | 24 hours |