A multicenter, randomized clinical trial has found that tranexamic acid (TXA) does not reduce the need for red blood cell (RBC) transfusions in patients undergoing open radical cystectomy for bladder cancer. The Tranexamic Acid During Cystectomy Trial (TACT), a double-blind, placebo-controlled study, challenges the prophylactic use of TXA in this surgical setting.
The study, published in JAMA Surgery, enrolled 353 patients across 10 academic centers between June 2013 and January 2021. Patients were randomized to receive either intravenous TXA (10 mg/kg loading dose followed by 5 mg/kg per hour) or a placebo during radical cystectomy. The primary outcome was the receipt of RBC transfusion up to 30 days after surgery.
The results showed that 37.0% of patients in the TXA group and 37.4% in the placebo group required RBC transfusions (relative risk, 0.99; 95% CI, 0.83-1.18). There were no significant differences in secondary outcomes, including the mean number of RBC units transfused (0.9 vs 1.1; P = .43), estimated blood loss (927 mL vs 963 mL; P = .52), intraoperative transfusion (28.3% vs 24.0%; P = .08), or venous thromboembolic events (3.5% vs 2.9%; P = .57).
Implications for Clinical Practice
Radical cystectomy, a common surgical procedure for bladder cancer, is associated with a high risk of blood loss and subsequent RBC transfusion. Previous studies have demonstrated the efficacy of TXA in reducing blood loss during cardiac and orthopedic surgeries, leading to the hypothesis that it could have similar benefits in radical cystectomy.
However, the TACT trial's findings do not support the routine use of TXA in this context. According to the researchers, "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 Design and Patient Population
The TACT trial enrolled patients with bladder cancer undergoing planned open radical cystectomy. The median age of participants was 69 years, and 74.5% were male. The intervention involved a loading dose of TXA (10 mg/kg) followed by a maintenance infusion (5 mg/kg per hour) for the duration of the surgery. The control group received a matching placebo.
The primary outcome was the proportion of patients receiving RBC transfusion up to 30 days post-surgery. Secondary outcomes included the number of RBC units transfused, estimated blood loss, intraoperative transfusion rates, and the incidence of venous thromboembolic events.
Limitations
The study authors noted that non-transfusion-related adverse events were similar between the two groups. The trial provides robust evidence against the routine use of TXA to reduce transfusions in radical cystectomy. Further research may explore the use of TXA in specific subgroups of patients or in combination with other blood-sparing strategies.
