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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05774691

Enrollment

1000

Registered

2023-03-20

Start date

2023-11-01

Completion date

2026-01-02

Last updated

2026-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Valve Stenosis

Keywords

TAVI, TAVR, Bleeding, Mortality, Allergy, Protamine

Brief 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.

Interventions

DRUGProtamine sulfate

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Intervention model description

Parallel Assignment

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Composite of all-cause mortality or type 1-4 bleeding	30 days after TAVI	According to the VARC-3 criteria

Secondary

Measure	Time frame	Description
All bleeding	30 days after TAVI	According to the VARC-3 criteria type 1-4 bleeding
Major, life-threatening or fatal bleeding	30 days after TAVI	According to the VARC-3 criteria type 2-4 bleeding
Major vascular complications	30 days after TAVI	According to the VARC-3 criteria
Cardiovascular mortality	30 days after TAVI	According to the VARC-3 criteria
All-cause mortality	30 days after TAVI	According to the VARC-3 criteria

Countries

Belgium, Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 21, 2026