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RECRUITINGPhase 4INTERVENTIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Aged \> 18 years - Undergoing transfemoral TAVI with any commercially available transcatheter heart valve - Provided written willing to sign a consent form Who Should NOT Join This Trial: - Documented protamine allergy or anaphylaxis - Recent PCI (\< 3 months before TAVI) - Planned arterial access via surgical cut-down Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Aged \> 18 years * Undergoing transfemoral TAVI with any commercially available transcatheter heart valve * Provided written informed consent Exclusion Criteria: * Documented protamine allergy or anaphylaxis * Recent PCI (\< 3 months before TAVI) * Planned arterial access via surgical cut-down

Treatments Being Tested

DRUG

Protamine sulfate

Routine protamine administration in a ratio of 1 IE per 1 IE of unfractionated heparin.

DRUG

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