Do Anesthesiologists Follow Guidelines on Perioperative Use of Tranexamic Acid?

Blood Loss, Surgical Clinical Trial

— Periop_TXA  

Official title:

Do Anesthesiologists Follow Guidelines on Perioperative Use of Tranexamic Acid?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05783648
• Other study ID #: SRB2023055
• Status: Completed
• Start date: July 3, 2023
• Est. completion date: August 29, 2023

Study information

• Verified date: March 2023
• Source: Erasme University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1726
• Est. completion date: August 29, 2023
• Est. primary completion date: August 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Loss, Surgical
• Blood Transfusion
• Tranexamic Acid

Intervention

Drug:
• Use of tranexamic acid
Percentage of correct use according to POISE-3 criteria of tranexamic acid

Locations

Country	Name	City	State
Belgium	Hôpital Universitaire de Bruxelles - Hôpital erasme	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Erasme University Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of correct use of TXA	Percentage of patients who received tranexamic acid correctly according to the POISE-3 criteria	12 hours
Primary	Comparison of percentage use of TXA before and after the release of TXA recommendations	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	12 hours
Secondary	Blood loss	Comparison of blood loss between correctly treated patients and not correctly treated patients according to the POISE-3 criteria	24 hours
Secondary	Transfusion	Comparison of blood transfusion between correctly treated patients and not correctly treated patients according to the POISE-3 criteria	24 hours