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

NCT05774691 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2026-05-20

No results posted yet for this study

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

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

Sponsors & Collaborators

  • St. Antonius Research Fund

    collaborator UNKNOWN

  • St. Antonius Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-01
Primary Completion
2026-01-02
Completion
2026-01-02

Countries

  • Belgium
  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05774691 on ClinicalTrials.gov