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RECRUITING
NCT05774691
PHASE4

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

Sponsor: St. Antonius Hospital

View on ClinicalTrials.gov

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.

Official title: Routine Versus Selective Protamine Administration to Reduce Bleeding Complications After Transcatheter Aortic Valve Implantation

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1000

Start Date

2023-11-01

Completion Date

2025-12

Last Updated

2025-11-26

Healthy Volunteers

No

Interventions

DRUG

Protamine sulfate

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

DRUG

Protamine sulfate

Selective protamine administration, in case of (threatening) bleeding

Locations (6)

A.S.Z. Aalst

Aalst, Belgium

University Hospitals Leuven

Leuven, Belgium

Maastricht UMC

Maastricht, Limburg, Netherlands

Leiden University Medical Center

Leiden, South Holland, Netherlands

St. Antonius Hospital

Nieuwegein, Utrecht, Netherlands

Amsterdam University Medical Center

Amsterdam, Netherlands