A recent study has found that tranexamic acid (TXA), commonly used to reduce bleeding during cardiac surgery, failed to reduce risk of seizures while increasing the need for blood transfusions.
PHRI Scientist Andre Lamy presented the findings of the large international DEPOSITION trial during a Late-Breaking Clinical Trial session at ACC.24. Simultaneously, the trial results were published in the Circulation AHA journal on April 8th.
The trial, involving 3,242 patients across16 sites in 6 countries, aimed to explore if topical TXA after surgery, compared with intravenous delivery during surgery, would reduce the risk of in-hospital seizure without increasing transfusion risks in cardiac surgery patients.
“The DEPOSITION trial represents the largest randomized sample to date of topical versus intravenous TXA in cardiac surgery” said Lamy, principal investigator of the study.
Among the participants, in-hospital seizures occurred in 4 of 1624 patients in the topical group and in 11 of 1628 patients in the intravenous group. Also, red blood cell transfusion occurred in 570 patients in the topical group and in 433 in the intravenous group.
Due to safety concerns for bleeding, the trial was stopped early following the Data and Safety Monitoring Board’s second prespecified review.
“While we had to end the trial early, a post hoc analysis demonstrated a significant reduction in any seizures and that most seizures were associated with intravenous TXA and air embolism from valve surgery. This is the first trial to clearly demonstrate the role of air embolism in post-operative seizure. These results encourage us to explore how we can optimize the administration of TXA to decrease seizure and bleeding after cardiac surgery.”
Dr. Lamy on DEPOSITION, “The trial is disappointing, but we’ve learned a lot. I think there is a message that is much broader than just cardiac surgery, in that we have to look at this drug with new eyes and new technologies to improve its performance.” #ACC24 pic.twitter.com/Jq9TcMwlzF
— ACC Media Center (@ACCmediacenter) April 8, 2024
The trial received funding from the Canadian Institutes of Health Research, PHRI, and McMaster University.