NCT05774691View on ClinicalTrials.gov

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

PHASE4RecruitingINTERVENTIONAL
Enrollment

1,000

Participants

Timeline

Start Date

November 1, 2023

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Aortic Valve Stenosis
Interventions
DRUG

Protamine sulfate

Routine protamine administration in a ratio of 1 mg per 100 IU of unfractionated heparin

DRUG

Protamine sulfate

Selective protamine administration, in case of (threatening) bleeding

Trial Locations (6)

Unknown

RECRUITING

A.S.Z. Aalst, Aalst

RECRUITING

University Hospitals Leuven, Leuven

NOT_YET_RECRUITING

Maastricht UMC, Maastricht

RECRUITING

Leiden University Medical Center, Leiden

RECRUITING

St. Antonius Hospital, Nieuwegein

NOT_YET_RECRUITING

Amsterdam University Medical Center, Amsterdam

All Listed Sponsors
collaborator

St. Antonius Research Fund

UNKNOWN

lead

St. Antonius Hospital

OTHER

NCT05774691 - Routine Versus Selective Protamine Administration to Reduce Bleeding Complications After Transcatheter Aortic Valve Implantation (POPular ACE TAVI) | Biotech Hunter | Biotech Hunter