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

Aortic Valve Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05774691
• Other study ID #: 2023-504205-36-00
• Status: Recruiting
• Phase: Phase 4
• Start date: November 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2024
• Source: St. Antonius Hospital
• Contact: Prof. J.M. ten Berg, MD, PhD
• Phone: 0031 088 320 3000
• Email: jurtenberg[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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
• Pregnancy

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Hemorrhage

Intervention

Drug:
• Protamine sulfate
Routine protamine administration in a ratio of 1 mg per 100 IU of unfractionated heparin
• Protamine sulfate
Selective protamine administration, in case of (threatening) bleeding

Locations

Country	Name	City	State
Belgium	A.S.Z. Aalst	Aalst
Belgium	University Hospitals Leuven	Leuven
Netherlands	Amsterdam University Medical Center	Amsterdam
Netherlands	Leiden University Medical Center	Leiden	South Holland
Netherlands	Maastricht UMC	Maastricht	Limburg
Netherlands	St. Antonius Hospital	Nieuwegein	Utrecht

Sponsors (2)

Lead Sponsor	Collaborator
St. Antonius Hospital	St. Antonius Research Fund

Countries where clinical trial is conducted

Belgium,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Anaphylaxis	According to the National Institute of Allergy and Infectious Disease criteria	30 days after TAVI
Other	Thromboembolic events	Composite of myocardial infarction, ischaemic stroke, transient ischaemic attack or non-cerebral distal embolization according to the VARC-3 criteria	30 days after TAVI
Primary	Composite of cardiovascular mortality or type 1-4 bleeding	According to the VARC-3 criteria	30 days after TAVI
Secondary	Haemoglobin level	mmol/L	30 days after TAVI
Secondary	Procedural haemostasis failure	Failure to achieve haemostasis at the arteriotomy site leading to alternative treatment (e.g. fem-stop device, or adjunctive endovascular ballooning/stenting)	30 days after TAVI
Secondary	Delayed haemostasis failure	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 cathlab.	30 days after TAVI
Secondary	Length of post-procedural stay	Post-procedural length of stay will be measured in the time (days) from procedure to discharge	30 days after TAVI
Secondary	Need for transfusion	Any bleeding requiring transfusion of 1 or more units of whole blood/RBC	30 days after TAVI
Secondary	All bleeding	According to the VARC-3 criteria type 1-4 bleeding	30 days after TAVI
Secondary	Major, life-threatening or fatal bleeding	According to the VARC-3 criteria type 2-4 bleeding	30 days after TAVI
Secondary	Major vascular complications	According to the VARC-3 criteria	30 days after TAVI
Secondary	Cardiovascular mortality	According to the VARC-3 criteria	30 days after TAVI
Secondary	All-cause mortality	According to the VARC-3 criteria	30 days after TAVI