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Do Anesthesiologists Follow Guidelines on Perioperative Use of Tranexamic Acid? (Periop_TXA)

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ClinicalTrials.gov Identifier: NCT05783648
Recruitment Status : Completed
First Posted : March 24, 2023
Last Update Posted : August 30, 2023
Sponsor:
Information provided by (Responsible Party):
Erasme University Hospital

Study Description
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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.


Condition or disease Intervention/treatment
Tranexamic Acid Blood Loss, Surgical Blood Transfusion Drug: Use of tranexamic acid

Study Design
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Study Type : Observational
Actual Enrollment : 1726 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Do Anesthesiologists Follow Guidelines on Perioperative Use of Tranexamic Acid?
Actual Study Start Date : July 3, 2023
Actual Primary Completion Date : August 25, 2023
Actual Study Completion Date : August 29, 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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.
 Drug: Use of tranexamic acid
Percentage of correct use according to POISE-3 criteria of tranexamic acid
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.
 Drug: Use of tranexamic acid
Percentage of correct use according to POISE-3 criteria of tranexamic acid


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05783648


Locations
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Belgium
Hôpital Universitaire de Bruxelles - Hôpital erasme
Brussels, Belgium, 1070
Sponsors and Collaborators
Erasme University Hospital
More Information
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Responsible Party: Erasme University Hospital
ClinicalTrials.gov Identifier: NCT05783648    
Other Study ID Numbers: SRB2023055
First Posted: March 24, 2023    Key Record Dates
Last Update Posted: August 30, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Blood Loss, Surgical
Hemorrhage
Pathologic Processes
Intraoperative Complications
Tranexamic Acid
 Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants