NCT05774691

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: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,000 (estimated)
• Sponsor: St. Antonius Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Aortic Valve Stenosis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-11-01
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2023-03-20
• Last updated: 2025-11-26

Locations

6 sites across 2 countries: Belgium, Netherlands