Tranexamic acid Cuts need for blood transfusions during hospitalization for non-cardiac surgery: Study
When hospitals were randomly assigned to treat patients undergoing higher-risk non-cardiac surgery with tranexamic acid (TXA) or a placebo, patients who received TXA needed significantly fewer blood transfusions and saw no increase in potentially life-threatening blood clots (thrombosis) after 90 days of follow-up, according to research presented at the 67th American Society of Hematology (ASH) Annual Meeting and Exposition.
“Our findings confirm that TXA reduces the need for blood transfusion in patients undergoing higher-risk non-cardiac surgery,” said lead study author Brett Houston, MD, PhD, an assistant professor at the University of Manitoba and a scientist with the Paul Albrechtsen Research Institute in Winnipeg, Canada. “We were also able to show that giving TXA is safe and does not increase the occurrence of dangerous blood clots within the three-month high-risk period after surgery.”
TXA is a generic drug that promotes blood clotting, which is essential to stop blood loss from injuries or during surgery. However, a blood clot can be life threatening when it forms inside a blood vessel and blocks blood flow to vital organs.
A 2019 international study of 40,000 patients found major bleeding to be the most common life-threatening complication following non-cardiac surgery. Another large international randomized trial, known as POISE-3, showed that, compared with patients who received a placebo, patients who received TXA immediately before and after non-cardiac surgery had significantly less serious bleeding and needed fewer blood transfusions, with no significant increase in heart attacks, strokes, or blood clots at 30 days.
The current study, known as TRACTION, was designed to build on the findings of POISE-3, Dr. Houston said. Participating hospitals – 10 medical centers in Canada – were randomly assigned to administer either TXA or a placebo to adult patients undergoing major non-cardiac surgical procedures that posed an elevated risk for post-surgical bleeding complications and blood clots. Every four weeks, hospitals in the TXA group switched to the placebo group and vice versa.
Patients received a first dose of TXA or the placebo intravenously within minutes of surgery initiation. At the discretion of the attending anesthesiologist, they then received a second dose either at the conclusion of the operation or as a continuous infusion throughout the procedure.
The study’s primary endpoints were the number of patients needing blood transfusions during their hospital stay and the number diagnosed with blood clots within 90 days.
Secondary endpoints included the number of units of blood transfused; the number of patients diagnosed with a heart attack, stroke, or blood clot while in the hospital; the number of patients admitted to intensive care; the number surviving at 90 days after surgery; and patients’ length of stay in the hospital.
The study’s results are based on the evaluation of 8,273 patients treated across the 10 participating hospitals. More than 60% of the patients underwent cancer surgery. Among patients treated with TXA, 7.4% received a blood transfusion while in the hospital compared with 9.8% of those treated with the placebo, a statistically significant difference. Patients treated with TXA needed significantly fewer units of blood (0.34 units on average) than those in the placebo group (2.5 units on average). The proportion of patients diagnosed with blood clots within 90 days was the same (2.1%) in both the TXA and placebo groups. No significant differences were seen in any of the secondary endpoints.
The finding that TXA use does not increase risk for blood clots during the 90-day post-surgical period of elevated risk may reassure many practitioners who have previously been hesitant to adopt the drug, Dr. Houston said. “We hope this data will also set practitioners’ minds at rest that giving the drug is safe,” she said.
Although the study was limited to Canada, it evaluated bleeding risk across a broad range of types of higher-risk non-cardiac surgery, Dr. Houston said, including gynecologic, urologic, spinal, blood-vessel, and cancer surgery. In addition, participating hospitals included both academic medical centers and community hospitals.
A limitation of the study is that participation was restricted to hospitals with sophisticated electronic medical records systems in place to transmit study data.
Findings from other studies suggest that the use of TXA could be successfully introduced as a hospital-level policy in the same way that other surgical safety practices, such as antibiotic administration to prevent infection and the use of surgical checklists have been adopted, Dr. Houston said. As a next step, she and her colleagues plan to work on educating physicians about the TRACTION findings and promoting the adoption of TXA administration as a standard practice during higher-risk non-cardiac surgery.
Reference:
Drug reduced need for blood transfusions during hospitalization for non-cardiac surgery, American Society of Hematology, Meeting: 67th American Society of Hematology (ASH) Annual Meeting and Exposition.
