Do Anesthesiologists Follow Guidelines on Perioperative Use of Tranexamic Acid? (Periop_TXA)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Brussels, Belgium, 1070
- Hôpital Universitaire de Bruxelles - Hôpital Erasme
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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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.
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Percentage of correct use according to POISE-3 criteria of tranexamic acid
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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.
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Percentage of correct use according to POISE-3 criteria of tranexamic acid
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Percentage of correct use of TXA
Time Frame: 12 hours
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Percentage of patients who received tranexamic acid correctly according to the POISE-3 criteria
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12 hours
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Comparison of percentage use of TXA before and after the release of TXA recommendations
Time Frame: 12 hours
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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
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12 hours
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Blood loss
Time Frame: 24 hours
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Comparison of blood loss between correctly treated patients and not correctly treated patients according to the POISE-3 criteria
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24 hours
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Transfusion
Time Frame: 24 hours
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Comparison of blood transfusion between correctly treated patients and not correctly treated patients according to the POISE-3 criteria
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24 hours
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SRB2023055
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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