Actively Recruiting
Routine Versus Selective Protamine Administration to Reduce Bleeding Complications After Transcatheter Aortic Valve Implantation (POPular ACE TAVI)
Led by St. Antonius Hospital · Updated on 2025-11-26
1000
Participants Needed
6
Research Sites
108 weeks
Total Duration
On this page
Sponsors
S
St. Antonius Hospital
Lead Sponsor
S
St. Antonius Research Fund
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Routine Versus Selective Protamine Administration to Reduce Bleeding Complications After Transcatheter Aortic Valve Implantation (POPular ACE TAVI)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged > 18 years
- Undergoing transfemoral TAVI with any commercially available transcatheter heart valve
- Provided written informed consent
You will not qualify if you...
- Documented protamine allergy or anaphylaxis
- Recent PCI (< 3 months before TAVI)
- Planned arterial access via surgical cut-down
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
A.S.Z. Aalst
Aalst, Belgium
Actively Recruiting
2
University Hospitals Leuven
Leuven, Belgium
Actively Recruiting
3
Maastricht UMC
Maastricht, Limburg, Netherlands
Not Yet Recruiting
4
Leiden University Medical Center
Leiden, South Holland, Netherlands
Actively Recruiting
5
St. Antonius Hospital
Nieuwegein, Utrecht, Netherlands
Actively Recruiting
6
Amsterdam University Medical Center
Amsterdam, Netherlands
Not Yet Recruiting
Research Team
P
Prof. J.M. ten Berg, MD, PhD
CONTACT
D
D.C. Overduin, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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