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

St. Antonius Hospital

Status and phase: Enrolling; Phase 4

Conditions: Aortic Valve Stenosis

Treatments: Drug: Protamine sulfate

Study type: Interventional

Funder types: Other

Identifiers

NCT05774691

2023-504205-36-00

Details and patient eligibility

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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,000 participants in 2 patient groups

Routine protamine administration

Active Comparator group

Description:

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

Treatment:

Drug: Protamine sulfate

Drug: Protamine sulfate

Selective protamine administration

Active Comparator group

Description:

Selective protamine administration, in case of (threatening) bleeding.

Treatment:

Drug: Protamine sulfate

Drug: Protamine sulfate