Do Anesthesiologists Follow Guidelines on Perioperative Use of Tranexamic Acid?

NCT05783648 | Completed

• 1 other identifier: SRB2023055
• Study Type: observational
• Target: 1,726
• Locations: 1 country
• Sites: 1

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.

Conditions

Tranexamic Acid; Blood Loss, Surgical; Blood Transfusion

Outcome Measures

Primary Outcomes (2)

• Percentage of correct use of TXA

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

  12 hours

• 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 Outcomes (2)

• Blood loss

  24 hours

• Transfusion

  24 hours

Study Arms (2)

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

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

Interventions

Use of tranexamic acid DRUG

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

After TXA recommendations; Before TXA recommendations

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Erasme University Hospital: lead

Study Sites (1)

Hôpital Universitaire de Bruxelles - Hôpital erasme

Brussels, 1070, Belgium

Location

MeSH Terms

Conditions

Blood Loss, Surgical

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2023
• First Posted: March 24, 2023
• Study Start: July 3, 2023
• Primary Completion: August 25, 2023
• Study Completion: August 29, 2023
• Last Updated: August 30, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)