Publication related to RSI or an RSI staff member
Tranexamic Acid During Radical Cystectomy: A Randomized Clinical Trial.
IMPORTANCE: 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. OBJECTIVE: 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. DESIGN, SETTING, AND PARTICIPANTS: 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. INTERVENTION: 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. MAIN OUTCOMES AND MEASURES: The primary outcome was receipt of RBC transfusion up to 30 days after surgery. RESULTS: 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. CONCLUSIONS AND RELEVANCE: 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. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01869413.
Authors
- Breau, Rodney H, Breau RH, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
- Lavallee, Luke T, Lavallee LT, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
- Cagiannos, Ilias, Cagiannos I, Ottawa Hospital, Ottawa, Ontario, Canada.
- Momoli, Franco, Momoli F, School of Epidemiology and Public Health, University of Ottawa, Ottawa, Ontario, Canada.
- Bryson, Gregory L, Bryson GL, Departments of Anesthesiology and Pain Medicine, University of Ottawa, Ottawa, Ontario, Canada.
- Kanji, Salmaan, Kanji S, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
- Morash, Christopher, Morash C, Ottawa Hospital, Ottawa, Ontario, Canada.
- Turgeon, Alexis F, Turgeon AF, Department of Anesthesiology and Critical Care Medicine, Division of Critical Care Medicine, Université Laval, Québec City, Québec, Canada.; Population Health and Optimal Health Practices Research Unit (Trauma-Emergency-Critical Care Medicine), CHU de Québec-Université Laval Research Center, Québec City, Québec, Canada.
- Zarychanski, Ryan, Zarychanski R, Department of Internal Medicine, University of Manitoba, Winnipeg, Manitoba, Canada.; Department of Medical Oncology and Haematology, Cancercare Manitoba, Winnipeg, Manitoba, Canada.
- Houston, Brett L, Houston BL, Department of Internal Medicine, University of Manitoba, Winnipeg, Manitoba, Canada.; Department of Medical Oncology and Haematology, Cancercare Manitoba, Winnipeg, Manitoba, Canada.
- McIsaac, Daniel I, McIsaac DI, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.; Departments of Anesthesiology and Pain Medicine, University of Ottawa, Ottawa, Ontario, Canada.
- Mallick, Ranjeeta, Mallick R, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
- Knoll, Greg A, Knoll GA, Department of Medicine (Nephrology), The Ottawa Hospital, Ottawa, Ontario, Canada.
- Kulkarni, Girish, Kulkarni G, Division of Urology, Department of Surgery, University of Toronto, Toronto, Ontario, Canada.
- Izawa, Jonathan, Izawa J, Department of Surgery & Oncology, Division of Urology, Western University, London, Ontario, Canada.
- Saad, Fred, Saad F, University of Montreal Hospital Center (CHUM), Montreal Cancer Institute/CRCHUM, Montréal, Québec, Canada.
- Kassouf, Wassim, Kassouf W, Department of Surgery (Urology), McGill University Health Center, Montréal, Québec, Canada.
- Fradet, Vincent, Fradet V, Department of Surgery (Urology), CHU de Québec - Université Laval, Québec City, Québec, Canada.
- Rendon, Ricardo, Rendon R, Department of Urology, Dalhousie University and Nova Scotia Health Authority, Halifax, Nova Scotia, Canada.
- Shayegan, Bobby, Shayegan B, Division of Urology, McMaster University, Hamilton, Ontario, Canada.
- Fairey, Adrian, Fairey A, Division of Urology, University of Alberta, Edmonton, Alberta, Canada.
- Drachenberg, Darrel E, Drachenberg DE, Urologic Oncologist, Section of Urology, Department of Surgery, University of Manitoba, Winnipeg, Manitoba, Canada.
- Fergusson, Dean, Fergusson D, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
IMPORTANCE: 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. OBJECTIVE: 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. DESIGN, SETTING, AND PARTICIPANTS: 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. INTERVENTION: 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. MAIN OUTCOMES AND MEASURES: The primary outcome was receipt of RBC transfusion up to 30 days after surgery. RESULTS: 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. CONCLUSIONS AND RELEVANCE: 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. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01869413.
