Topical administration of tranexamic acid may be inferior to intravenous administration in patients undergoing heart surgery.
Tranexamic acid is often used to reduce excessive bleeding during surgical procedures; however, patients undergoing heart surgery may face an increased risk of seizure when receiving the drug.
In the DEPOSITION trial, results of which were presented by Lamy et al at the American College of Cardiology (ACC) Annual Scientific Session 2024 and simultaneously published in Circulation, researchers recruited about 85% (n= 3,224/3,800) of the intended patients undergoing either open heart surgery, coronary artery bypass surgery, or both procedures. The patients involved in the trial were randomly assigned to receive 5 to 10 g of either topical or intravenous tranexamic acid alongside respective intravenous or topical placebo.
The trial was ended early because of concerns regarding the safety of topical tranexamic acid during an interim analysis.
Patients who received topical tranexamic acid experienced a 31% increased risk of bleeding events. Further, 35.1% of the patients who received topical tranexamic acid vs 26.8% of those who received intravenous tranexamic acid required blood transfusions. The researchers hypothesized that the topical administration of the drug may not be absorbed as effectively as the intravenous administration. Four patients who received topical tranexamic acid vs 11 patients who received intravenous tranexamic acid experienced seizures—which were more common in those who underwent open heart surgery compared with those who underwent coronary artery bypass surgery.
Further pharmacokinetic studies may be needed to optimize the dosing and minimize the risks of intravenous tranexamic acid.
“The signal for harm with topical administration for increased blood transfusions was clearly significant. Topical administration in its current form is inferior to intravenous [tranexamic acid] and should not be used,” concluded lead study author Andre Lamy, MD, Professor of Surgery at McMaster University and a cardiac surgeon at Hamilton Health Sciences.
