Routine Versus Selective Protamine Administration to Reduce Bleeding Complications After Transcatheter Aortic Valve Implantation (POPular ACE TAVI)
Key facts
- Who runs it
- St. Antonius Hospital
- Where
- Belgium and Netherlands6 sites in 2 countriesChoose a country to see its sites
- Trial code
- NCT05774691
- EU 2023-504205-36-00
- U1111-1289-5421
- Status
- Completed
- Phase
- Phase 4
- People taking part
- 1,000 people enrolled
- Started
- 1 Nov 2023
- Ended
- 2 Jan 2026
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Protamine sulfate
- Record updated
- 20 May 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- Aged > 18 years
- Undergoing transfemoral TAVI with any commercially available transcatheter heart valve
- Provided written informed consent
Who cannot take part
- Recent PCI (< 3 months before TAVI)
- Planned arterial access via surgical cut-down
- Documented protamine allergy or anaphylaxis
This trial has no sites in United States.
It has sites in 2 countries. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
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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.
The 2 groups in the trial
- Routine protamine administrationExisting treatment, for comparison
Routine protamine administration in a ratio of 1 IE per 1 IE of unfractionated heparin.
Treatment: Protamine sulfate
- Selective protamine administrationExisting treatment, for comparison
Selective protamine administration, in case of (threatening) bleeding.
Treatment: Protamine sulfate
Data and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- Routine Versus Selective Protamine Administration to Reduce Bleeding Complications After Transcatheter Aortic Valve Implantation
- Record updated
- 20 May 2026