Overview

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

Status:
Not yet recruiting

Trial end date:
2025-12-31

Target enrollment:

Participant gender:

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 cardiovascular mortality or bleeding within 30 days after transcatheter aortic valve implantation.

Phase:

Phase 4

Details

Lead Sponsor:

St. Antonius Hospital

Collaborator:

St. Antonius Research Fund

Treatments:

Calcium heparin
Heparin
Protamines