Antagonization of Heparin With Protamine Sulfate to Lower All Neurological Ischemic and Hemorrhagic Events After Transcatheter Aortic Valve Implantation for Aortic Stenosis

What this Trial Is About

Researchers are studying a treatment approach for patients with aortic valve stenosis undergoing transcatheter aortic valve replacement (TAVR). This condition affects the heart valve and can cause serious complications. The study focuses on the use of heparin, a medication given during the procedure to prevent blood clots, and the possible benefits of reversing heparin's effects with protamine sulfate to reduce bleeding and vascular complications. This is a phase 3 randomized trial aiming to compare systematic use of protamine sulfate against usual care to improve safety outcomes. Participants will be randomly assigned to one of two groups: one group will receive protamine sulfate after TAVR to reverse the effects of heparin based on activated clotting time (ACT) measurements, while the other group will not receive protamine unless bleeding events require intervention. Protamine sulfate will be given as a slow infusion to neutralize heparin activity. The study includes patients eligible for transfemoral TAVR, and the treatment is carefully monitored to ensure reversal of heparin's anti-IIa activity. During the study, participants will be followed from the TAVR procedure until hospital discharge or up to 30 days. Researchers will assess a composite of ischemic and bleeding events, stroke, transient ischemic attack, myocardial infarction, and the need for red blood cell transfusion. Safety and adverse outcomes will be tracked both during the hospital stay and up to 12 months after the procedure. This monitoring includes evaluating vascular and bleeding complications and overall in-hospital stay outcomes.

Antagonization of Heparin With Protamine Sulfate After TAVI