Clinical trial NCT05783648: Do Anesthesiologists Follow Guidelines on Perioperative Use of Tranexamic Acid?
Official title: Do Anesthesiologists Follow Guidelines on Perioperative Use of Tranexamic Acid?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tranexamic Acid
Blood Loss, Surgical
Blood Transfusion
Lead sponsor: Erasme University Hospital
Sponsor class: OTHER
First posted: 2023-03-24
Enrollment: 1726
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing inpatient surgery either between oct 1st 2021 and dec 31st 2021 or oct 1st 2022 and dec 31st 2022

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of correct use of TXA
timeFrame: 12 hours
measure: Comparison of percentage use of TXA before and after the release of TXA recommendations
timeFrame: 12 hours
Secondary outcomes:
measure: Blood loss
timeFrame: 24 hours
measure: Transfusion
timeFrame: 24 hours
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Hôpital Universitaire de Bruxelles - Hôpital erasme
Study officials:
References: