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Clinical Trials/NCT05783648
NCT05783648CompletedNot Applicable

Do Anesthesiologists Follow Guidelines on Perioperative Use of Tranexamic Acid?

Erasme University Hospital1 site in 1 country1,726 target enrollmentStarted: July 3, 2023Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
1,726
Locations
1
Primary Endpoint
Comparison of percentage use of TXA before and after the release of TXA recommendations

Study Overview

Brief Summary

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 Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

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.

Intervention: 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.

Intervention: Use of tranexamic acid (Drug)

Outcomes

Primary Outcomes

Comparison of percentage use of TXA before and after the release of TXA recommendations

Time Frame: 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

Time Frame: 12 hours

Percentage of patients who received tranexamic acid correctly according to the POISE-3 criteria

Secondary Outcomes

  • Transfusion(24 hours)
  • Blood loss(24 hours)

Investigators

Sponsor
Erasme University Hospital
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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