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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
1,000
Routine protamine administration in a ratio of 1 IE per 1 IE of unfractionated heparin.
Selective protamine administration, in case of (threatening) bleeding
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
Composite of all-cause mortality or type 1-4 bleeding
According to the VARC-3 criteria
Time frame: 30 days after TAVI
All bleeding
According to the VARC-3 criteria type 1-4 bleeding
Time frame: 30 days after TAVI
Major, life-threatening or fatal bleeding
According to the VARC-3 criteria type 2-4 bleeding
Time frame: 30 days after TAVI
Major vascular complications
According to the VARC-3 criteria
Time frame: 30 days after TAVI
Cardiovascular mortality
According to the VARC-3 criteria
Time frame: 30 days after TAVI
All-cause mortality
According to the VARC-3 criteria
Time frame: 30 days after TAVI
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