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
St. Antonius Hospital
1,000 participants
Nov 1, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria3
- Aged > 18 years
- Undergoing transfemoral TAVI with any commercially available transcatheter heart valve
- Provided written informed consent
Exclusion Criteria3
- Documented protamine allergy or anaphylaxis
- Recent PCI (< 3 months before TAVI)
- Planned arterial access via surgical cut-down
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Interventions
Routine protamine administration in a ratio of 1 IE per 1 IE of unfractionated heparin.
Selective protamine administration, in case of (threatening) bleeding
Locations(6)
View Full Details on ClinicalTrials.gov
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NCT05774691