Clinical Trials Logo

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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05783648
Study type Observational
Source Erasme University Hospital
Contact
Status Completed
Phase
Start date July 3, 2023
Completion date August 29, 2023

See also
  Status Clinical Trial Phase
Completed NCT04114253 - QStat in Liver Transplant
Recruiting NCT05077124 - Safe and Timely Antithrombotic Removal (STAR) Registry
Active, not recruiting NCT03651154 - Hypovolemic Phlebotomy to Reduce Blood Transfusions in Major Hepatic Resections N/A
Recruiting NCT04519593 - ABSOLUTELY: A Temporary Uterine Blood Supply Occlusion for Laparoscopic Myomectomy in Patients With UTErine LeiomYoma N/A
Completed NCT02043132 - Tranexamic Acid in Reverse Total Shoulder Arthroplasty Phase 2/Phase 3
Withdrawn NCT00861367 - Prospective Double-blind Study for the Use of Aspirin During Transurethral Surgery of the Bladder or the Prostate N/A
Terminated NCT03246919 - Ideal Time of Oxytocin Infusion During Cesarean Section Phase 4
Completed NCT04443920 - Tranexamic Acid for Total Knee Arthroscopy Phase 4
Withdrawn NCT04933253 - Mediastinal Temperature and Post-operative Bleeding N/A
Recruiting NCT02938962 - Intravenous vs. Topical Tranexamic Acid in Revision THA (VITALITY-X) Phase 4
Recruiting NCT02130752 - Ultrasonic Scalpel vs. Monopolar Electrocautery for D2 Distal Gastric Carcinoma Surgery N/A
Recruiting NCT05164809 - Effect of Electrosurgery on Blood Loss and Intraoperative Transfusions in Musculoskeletal Tumor Surgery
Not yet recruiting NCT04574128 - Retransfusion or Not of Cardiotomy Blood N/A
Completed NCT02911831 - IV Tranexamic Acid Prior to Hysterectomy Early Phase 1
Completed NCT02740374 - Evaluation of Thromboelastometry (ROTEM) During Spinal Surgery N/A
Enrolling by invitation NCT05474027 - Reducing Hypotensive Anesthesia Use With TXA During Orthognathic Surgery Phase 4
Completed NCT05391607 - Comparison Between Hyperoncotic and Isooncotic Albumin to Support Blood Loss Replacement Phase 4
Completed NCT03152461 - Evaluation of the Clinical Performance of the Quantra System With the Quantra Surgical Cartridge
Recruiting NCT02441751 - Intraoperative Volume Management and QT Interval
Completed NCT01053169 - Observational Study of Prophylaxis and Treatment of Acute Perioperative Bleeding With Beriplex® P/N (Probe Study) N/A