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Routine Versus Selective Protamine Administration to Reduce Bleeding Complications After Transcatheter Aortic Valve Implantation (POPular ACE TAVI)

Aortic Valve Stenosis Clinical Trial

Official title:
Routine Versus Selective Protamine Administration to Reduce Bleeding Complications After Transcatheter Aortic Valve Implantation

Clinical Trial Summary

Heparin reversal by protamine administration after transcatheter aortic valve implantation (TAVI) may reduce bleeding events. However, protamine can also cause life-threatening allergic reactions. High-quality evidence regarding the clinical safety and efficacy of routine protamine administration after TAVI is lacking. The aim of this clinical trial is to determine if routine protamine administration, compared with selective protamine administration, reduces the risk of cardiovascular mortality or bleeding within 30 days after transcatheter aortic valve implantation.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05774691
Study type Interventional
Source St. Antonius Hospital
Contact Prof. J.M. ten Berg, MD, PhD
Phone 0031 088 320 3000
Email jurtenberg@gmail.com
Status Recruiting
Phase Phase 4
Start date November 1, 2023
Completion date December 31, 2025
View Details
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