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Completed

NCT Number: NCT05783648

Do Anesthesiologists Follow Guidelines on Perioperative Use of Tranexamic Acid?

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Universitaire de Bruxelles - Hôpital erasme

Brussels, 1070, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Use of tranexamic acid

Drug

Percentage of correct use according to POISE-3 criteria of tranexamic acid

Primary outcomes

  1. Percentage of correct use of TXA

    Time frame: 12 hours

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

  2. 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

Secondary outcomes

  1. Blood loss

    Time frame: 24 hours

    Comparison of blood loss between correctly treated patients and not correctly treated patients according to the POISE-3 criteria

  2. Transfusion

    Time frame: 24 hours

    Comparison of blood transfusion between correctly treated patients and not correctly treated patients according to the POISE-3 criteria

Sponsors and collaborators

Lead sponsor

Erasme University Hospital

Other

Registry information

Acronym: Periop_TXA

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 24, 2023
Registry last updated
Aug 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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