Study on Protamine Sulfate for Reducing Bleeding and Ischemic Events in Adults with Severe Aortic Stenosis Undergoing Transcatheter Aortic Valve Replacement

This clinical trial is focused on patients with severe aortic stenosis, a condition where the heart's aortic valve narrows, affecting blood flow. These patients are scheduled to undergo a procedure called transcatheter aortic valve replacement (TAVR), which is a minimally invasive method to replace the narrowed valve. The study will use a treatment called protamine sulfate, which is a medication used to reverse the effects of another drug called heparin, often used during surgeries to prevent blood clots.

The purpose of the study is to evaluate the benefits of using protamine sulfate after the TAVR procedure, specifically looking at its impact on reducing major bleeding and major ischemic events, which are serious conditions where blood flow to the heart or brain is reduced. Participants in the study will receive either protamine sulfate or a placebo after their TAVR procedure. The study will monitor the participants for any bleeding or ischemic events for up to 60 hours after the procedure.

Throughout the study, researchers will also observe other outcomes, such as the rate of mortality in the hospital, any additional surgeries needed, and the overall recovery of the heart valve function. The study aims to provide valuable information on the safety and effectiveness of protamine sulfate in improving outcomes for patients undergoing TAVR. This research is expected to continue until early 2027, with recruitment starting in 2025.