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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
St. Antonius Hospital·Phase 4·ClinicalTrials.gov·drugNot yet recruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Aortic Valve Stenosis
Drug/Device/Intervention
Protamine sulfate
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
St. Antonius Hospital
Location
Aalst,Leuven,Maastricht,Leiden,Nieuwegein, Belgium,Netherlands
Timeline & enrollment
Phase
Phase 4
Start date
Jun 01, 2023
End date
Dec 31, 2025
Enrollment
1000 participants
Primary outcome

Composite of cardiovascular mortality or type 1-4 bleeding

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.

ICD-10 classifications
Aortic (valve) stenosisAortic (valve) stenosis with insufficiencyCongenital stenosis of aortic valveStenosis of aortaRheumatic aortic stenosis
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05774691
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT05774691 through Pure Global AI's free database. This Phase 4 trial is sponsored by St. Antonius Hospital and is currently Not yet recruiting. The study focuses on Aortic Valve Stenosis. Target enrollment is 1000 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.