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Completed

NCT Number: NCT05774691

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

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.

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Key information

Conditions

Aortic Valve Stenosis Aortic Valve Disease Cardiovascular Diseases Heart Diseases Heart Valve Diseases Hemorrhage Hypersensitivity Immune System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

A.S.Z. Aalst, Aalst, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged > 18 years
  • Undergoing transfemoral TAVI with any commercially available transcatheter heart valve
  • Provided written informed consent

Exclusion criteria

  • Documented protamine allergy or anaphylaxis
  • Recent PCI (< 3 months before TAVI)
  • Planned arterial access via surgical cut-down

Treatment and study plan

Protamine sulfate

Drug

Routine protamine administration in a ratio of 1 IE per 1 IE of unfractionated heparin.

Other names: Routine heparin reversal

Primary outcomes

  1. Composite of all-cause mortality or type 1-4 bleeding

    Time frame: 30 days after TAVI

    According to the VARC-3 criteria

Secondary outcomes

  1. All bleeding

    Time frame: 30 days after TAVI

    According to the VARC-3 criteria type 1-4 bleeding

  2. Major, life-threatening or fatal bleeding

    Time frame: 30 days after TAVI

    According to the VARC-3 criteria type 2-4 bleeding

  3. Major vascular complications

    Time frame: 30 days after TAVI

    According to the VARC-3 criteria

  4. Cardiovascular mortality

    Time frame: 30 days after TAVI

    According to the VARC-3 criteria

  5. All-cause mortality

    Time frame: 30 days after TAVI

    According to the VARC-3 criteria

Other outcomes

  1. Safety endpoint: Anaphylaxis

    Time frame: 30 days after TAVI

    According to the National Institute of Allergy and Infectious Disease criteria

  2. Safety endpoint: Thromboembolic events

    Time frame: 30 days after TAVI

    Composite of myocardial infarction, ischaemic stroke, transient ischaemic attack or non-cerebral distal embolization according to the VARC-3 criteria

  3. Neurologic events

    Time frame: 30 days after TAVI

    According to the VARC-3 criteria

  4. Hospitalization

    Time frame: 30 days after TAVI

    According to the VARC-3 criteria

  5. Vascular and access-related complications

    Time frame: 30 days after TAVI

    According to the VARC-3 criteria

  6. Cardiac structural complications

    Time frame: 30 days after TAVI

    According to the VARC-3 criteria

  7. Other procedural or valve-related complications

    Time frame: 30 days after TAVI

    According to the VARC-3 criteria

  8. New conduction disturbances and arrhythmias

    Time frame: 30 days after TAVI

    According to the VARC-3 criteria

  9. Acute kidney injury

    Time frame: 30 days after TAVI

    According to the VARC-3 criteria

  10. Myocardial infarction

    Time frame: 30 days after TAVI

    According to the VARC-3 criteria

  11. Bioprosthetic valve dysfunction

    Time frame: 30 days after TAVI

    According to the VARC-3 criteria

  12. Leaflet thickening and reduced motion

    Time frame: 30 days after TAVI

    According to the VARC-3 criteria

  13. Clinically significant valve thrombosis

    Time frame: 30 days after TAVI

    According to the VARC-3 criteria

  14. Time to hemostasis

    Time frame: 30 days after TAVI

    Is defined as elapsed time after sheath removal and first observed and confirmed arterial hemostasis.

  15. Haemoglobin level

    Time frame: 30 days after TAVI

  16. Need for transfusion

    Time frame: 30 days after TAVI

    Any bleeding requiring transfusion of 1 or more units of whole blood/RBC

  17. Procedural haemostasis failure

    Time frame: 30 days after TAVI

    Procedural haemostasis failure is defined as failure to achieve haemostasis at the arteriotomy site within 20 minutes or leading to alternative treatment (e.g. fem-stop device, or adjunctive endovascular ballooning/stenting).

  18. Delayed haemostasis failure

    Time frame: 30 days after TAVI

    The occurrence of bleeding requiring prolonged manual compression or alternative interventions (new pressure bandage, fem-stop device, endovascular or surgical repair) after initial haemostasis was achieved and patient is no longer in the catheterization laboratory.

  19. Post-procedural length of stay

    Time frame: 30 days after TAVI

    Post-procedural length of stay will be measured in the time (days) from procedure to discharge.

  20. Freedom from mortality

    Time frame: 30 days after TAVI

    According to the VARC-3 criteria

  21. Successful access, delivery of the device, and retrieval of the delivery system

    Time frame: 30 days after TAVI

    According to the VARC-3 criteria

  22. Correct positioning of a single prosthetic heart valve into the proper anatomical location

    Time frame: 30 days after TAVI

    According to the VARC-3 criteria

  23. Freedom from surgery or intervention related to the device or to a major vascular or access-related, or cardiac structural complication

    Time frame: 30 days after TAVI

    According to the VARC-3 criteria

  24. Technical success

    Time frame: 30 days after TAVI

    According to the VARC-3 criteria

  25. Freedom from surgery or intervention related to the device or to a major vascular or access-related or cardiac structural complication

    Time frame: 30 days after TAVI

    According to the VARC-3 criteria

  26. Intended performance of the valve (mean gradient <20 mmHg, peak velocity <3 m/s, Doppler velocity index ≥0.25, and less than moderate aortic regurgitation)

    Time frame: 30 days after TAVI

    According to the VARC-3 criteria

  27. Freedom from all-cause mortality

    Time frame: 30 days after TAVI

    According to the VARC-3 criteria

  28. Freedom from all stroke

    Time frame: 30 days after TAVI

    According to the VARC-3 criteria

  29. Freedom from VARC type 2-4 bleeding

    Time frame: 30 days after TAVI

    According to the VARC-3 criteria

  30. Freedom from major vascular, access-related, or cardiac structural complication

    Time frame: 30 days after TAVI

    According to the VARC-3 criteria

  31. Freedom from acute kidney injury stage 3 or 4

    Time frame: 30 days after TAVI

    According to the VARC-3 criteria

  32. Freedom from moderate or severe aortic regurgitation

    Time frame: 30 days after TAVI

    According to the VARC-3 criteria

  33. Freedom from new permanent pacemaker due to procedure-related conduction abnormalities

    Time frame: 30 days after TAVI

    According to the VARC-3 criteria

  34. Freedom from surgery or intervention related to the device

    Time frame: 30 days after TAVI

    According to the VARC-3 criteria

Sponsors and collaborators

Lead sponsor

St. Antonius Hospital

Other

Collaborators

  • St. Antonius Research Fund

Registry information

Official study title

Routine Versus Selective Protamine Administration to Reduce Bleeding Complications After Transcatheter Aortic Valve Implantation

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Mar 20, 2023
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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