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Routine Versus Selective Protamine Administration to Reduce Bleeding Complications After Transcatheter Aortic Valve Implantation (POPular ACE TAVI)
Sponsor: St. Antonius Hospital
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 all-cause mortality or clinically relevant bleeding within 30 days after transcatheter aortic valve implantation.
Official title: Routine Versus Selective Protamine Administration to Reduce Bleeding Complications After Transcatheter Aortic Valve Implantation
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1000
Start Date
2023-11-01
Completion Date
2025-12
Last Updated
2025-11-26
Healthy Volunteers
No
Conditions
Interventions
Protamine sulfate
Routine protamine administration in a ratio of 1 IE per 1 IE of unfractionated heparin.
Protamine sulfate
Selective protamine administration, in case of (threatening) bleeding
Locations (6)
A.S.Z. Aalst
Aalst, Belgium
University Hospitals Leuven
Leuven, Belgium
Maastricht UMC
Maastricht, Limburg, Netherlands
Leiden University Medical Center
Leiden, South Holland, Netherlands
St. Antonius Hospital
Nieuwegein, Utrecht, Netherlands
Amsterdam University Medical Center
Amsterdam, Netherlands