A new study published in The New England Journal of Medicine finds that intraoperative tranexamic acid reduced red-cell transfusions across major noncardiac surgeries without increasing the risk of dangerous blood clots.
The study was sponsored and coordinated by the University of Manitoba (UM) and co-led by researchers at UM and The Ottawa Hospital, which calls it “a landmark clinical trial.”
The multicenter, double-blind, cluster-randomized, placebo-controlled trial involved 8,273 patients undergoing noncardiac surgery who were at high risk for red-cell transfusion. Ten hospitals were randomly assigned at four-week intervals to a hospital-wide policy of intraoperative tranexamic acid or placebo. Oncologic surgery accounted for 60.5% of the procedures.
The percentage of patients who received a red-cell transfusion during hospitalization was 7.4% (306 of 4,156 procedures) in the tranexamic acid group and 9.8% (403 of 4,117 procedures) in the placebo group. Venous thromboembolism within 90 days occurred in 2.1% of patients in each group, meeting the criterion for noninferiority.
The researchers concluded, “Among patients undergoing major noncardiac surgery, a hospital policy of tranexamic acid administration resulted in a lower incidence of red-cell transfusion than placebo administration, and tranexamic acid was noninferior to placebo with regard to diagnosis of venous thromboembolism.
The Ottawa Hospital stated in an article on its website that “tranexamic acid is an inexpensive drug that prevents excessive bleeding and stabilizes blood clots.” Although tranexamic acid has been used in cardiac and some orthopedic surgeries for decades, the hospital noted that surgeons “have been uncertain if it can safely be used in other major surgeries, especially cancer surgeries.”
The trial, it stated, sought to determine “if tranexamic acid reduced bleeding and blood transfusion without increasing the risk of clots.” The results, it stated, “support expanding its use to all major surgeries where patients face a high risk of blood loss.”
Read The Ottawa Hospital’s full article, which features comments from the researchers in the significant and potential impact of the study, here. Access the full New England Journal of Medicine study here.
