Hôpital Universitaire de Bruxelles - Hôpital erasme
Brussels, 1070, Belgium
NCT Number: NCT05783648
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Observational
Brussels, 1070, Belgium
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Percentage of correct use according to POISE-3 criteria of tranexamic acid
Time frame: 12 hours
Percentage of patients who received tranexamic acid correctly according to the POISE-3 criteria
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
Time frame: 24 hours
Comparison of blood loss between correctly treated patients and not correctly treated patients according to the POISE-3 criteria
Time frame: 24 hours
Comparison of blood transfusion between correctly treated patients and not correctly treated patients according to the POISE-3 criteria
Erasme University Hospital
Other
Acronym: Periop_TXA
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.
Published trials that share one or more normalized conditions with this study.
NCT04635007
Blood Loss, Surgical, Cesarean Section Complications
Cairo, Kasr El Ainy, Egypt
View Trial DetailsNCT06038981
Bariatric Surgery, Blood Loss, Surgical
Gdansk, Poland
View Trial DetailsNCT05874583
Arthroplasty, Replacement, Hip, Arthroplasty, Replacement, Knee
La Marsa, Tunis Governorate, Tunisia
View Trial DetailsNCT04911413
Blood Transfusion, Cardiac Surgical Procedures
Beijing, Beijing Municipality, China
View Trial Details