Among cancer surgeries, patients requiring open radical cystectomy have the highest risk of red blood cell (RBC) transfusion. Prophylactic tranexamic acid (TXA) reduces blood loss during cardiac and orthopedic surgery, and it is possible that similar effects of TXA would be observed during radical cystectomy.
To determine whether TXA, administered before incision and for the duration of radical cystectomy, reduced the number of RBC transfusions received by patients up to 30 days after surgery.
The Tranexamic Acid During Cystectomy Trial (TACT) was a double-blind, placebo-controlled, randomized clinical trial with enrollment between June 2013 and January 2021. This multicenter trial was conducted in 10 academic centers. A consecutive sample of patients was eligible if the patients had a planned open radical cystectomy for the treatment of bladder cancer.
Before incision, patients in the intervention arm received a loading dose of intravenous TXA, 10 mg/kg, followed by a maintenance infusion of 5 mg/kg per hour for the duration of the surgery. In the control arm, patients received indistinguishable matching placebo.
The primary outcome was receipt of RBC transfusion up to 30 days after surgery.
A total of 386 patients were assessed for eligibility, and 33 did not meet eligibility. Of 353 randomized patients (median [IQR] age, 69 [62-75] years; 263 male [74.5%]), 344 were included in the intention-to-treat analysis. RBC transfusion up to 30 days occurred in 64 of 173 patients (37.0%) in the TXA group and 64 of 171 patients (37.4%) in the placebo group (relative risk, 0.99; 95% CI, 0.83-1.18). There were no differences in secondary outcomes among the TXA group vs placebo group including mean (SD) number of RBC units transfused (0.9 [1.5] U vs 1.1 [1.8] U; P = .43), estimated blood loss (927 [733] mL vs 963 [624] mL; P = .52), intraoperative transfusion (28.3% [49 of 173] vs 24.0% [41 of 171]; P = .08), or venous thromboembolic events (3.5% [6 of 173] vs 2.9% [5 of 171]; P = .57). Non-transfusion-related adverse events were similar between groups.
Results of this randomized clinical trial reveal that TXA did not reduce blood transfusion in patients undergoing open radical cystectomy for bladder cancer. Based on this trial, routine use of TXA during open radical cystectomy is not recommended.
ClinicalTrials.gov Identifier: NCT01869413.
JAMA surgery. 2024 Oct 02 [Epub ahead of print]
Rodney H Breau, Luke T Lavallée, Ilias Cagiannos, Franco Momoli, Gregory L Bryson, Salmaan Kanji, Christopher Morash, Alexis F Turgeon, Ryan Zarychanski, Brett L Houston, Daniel I McIsaac, Ranjeeta Mallick, Greg A Knoll, Girish Kulkarni, Jonathan Izawa, Fred Saad, Wassim Kassouf, Vincent Fradet, Ricardo Rendon, Bobby Shayegan, Adrian Fairey, Darrel E Drachenberg, Dean Fergusson
Ottawa Hospital Research Institute, Ottawa, Ontario, Canada., Ottawa Hospital, Ottawa, Ontario, Canada., School of Epidemiology and Public Health, University of Ottawa, Ottawa, Ontario, Canada., Departments of Anesthesiology and Pain Medicine, University of Ottawa, Ottawa, Ontario, Canada., Department of Anesthesiology and Critical Care Medicine, Division of Critical Care Medicine, Université Laval, Québec City, Québec, Canada., Department of Internal Medicine, University of Manitoba, Winnipeg, Manitoba, Canada., Department of Medicine (Nephrology), The Ottawa Hospital, Ottawa, Ontario, Canada., Division of Urology, Department of Surgery, University of Toronto, Toronto, Ontario, Canada., Department of Surgery & Oncology, Division of Urology, Western University, London, Ontario, Canada., University of Montreal Hospital Center (CHUM), Montreal Cancer Institute/CRCHUM, Montréal, Québec, Canada., Department of Surgery (Urology), McGill University Health Center, Montréal, Québec, Canada., Department of Surgery (Urology), CHU de Québec - Université Laval, Québec City, Québec, Canada., Department of Urology, Dalhousie University and Nova Scotia Health Authority, Halifax, Nova Scotia, Canada., Division of Urology, McMaster University, Hamilton, Ontario, Canada., Division of Urology, University of Alberta, Edmonton, Alberta, Canada., Urologic Oncologist, Section of Urology, Department of Surgery, University of Manitoba, Winnipeg, Manitoba, Canada.