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

Sponsor

St. Antonius Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05774691

Collaborator

St. Antonius Research Fund (Other)

1,000

Enrollment

Locations

Arms

Anticipated Duration (Months)

200

Patients Per Site

6.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Aortic Valve Stenosis	Drug: Protamine sulfate Drug: Protamine sulfate	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1000 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Parallel AssignmentParallel Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2025

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Routine protamine administration Routine protamine administration in a ratio of 1 mg per 100 IU of unfractionated heparin.	Drug: Protamine sulfate Routine protamine administration in a ratio of 1 mg per 100 IU of unfractionated heparin Other Names: Routine heparin reversal
Active Comparator: Selective protamine administration Selective protamine administration, in case of (threatening) bleeding.	Drug: Protamine sulfate Selective protamine administration, in case of (threatening) bleeding Other Names: Selective heparin reversal

Arm

Intervention/Treatment

Active Comparator: Routine protamine administration

Routine protamine administration in a ratio of 1 mg per 100 IU of unfractionated heparin.

Drug: Protamine sulfate

Routine protamine administration in a ratio of 1 mg per 100 IU of unfractionated heparin

Other Names:

Routine heparin reversal

Active Comparator: Selective protamine administration

Selective protamine administration, in case of (threatening) bleeding.

Drug: Protamine sulfate

Selective protamine administration, in case of (threatening) bleeding

Other Names:

Selective heparin reversal

Outcome Measures

Primary Outcome Measures

Composite of cardiovascular mortality or type 1-4 bleeding [30 days after TAVI]
According to the VARC-3 criteria

Secondary Outcome Measures

Haemoglobin level [30 days after TAVI]
mmol/L
Procedural haemostasis failure [30 days after TAVI]
Failure to achieve haemostasis at the arteriotomy site leading to alternative treatment (e.g. fem-stop device, or adjunctive endovascular ballooning/stenting)
Delayed haemostasis failure [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 cathlab.
Length of post-procedural stay [30 days after TAVI]
Post-procedural length of stay will be measured in the time (days) from procedure to discharge
Need for transfusion [30 days after TAVI]
Any bleeding requiring transfusion of 1 or more units of whole blood/RBC
All bleeding [30 days after TAVI]
According to the VARC-3 criteria type 1-4 bleeding
Major, life-threatening or fatal bleeding [30 days after TAVI]
According to the VARC-3 criteria type 2-4 bleeding
Major vascular complications [30 days after TAVI]
According to the VARC-3 criteria
Cardiovascular mortality [30 days after TAVI]
According to the VARC-3 criteria
All-cause mortality [30 days after TAVI]
According to the VARC-3 criteria

Other Outcome Measures

Anaphylaxis [30 days after TAVI]
According to the National Institute of Allergy and Infectious Disease criteria
Thromboembolic events [30 days after TAVI]
Composite of myocardial infarction, ischaemic stroke, transient ischaemic attack or non-cerebral distal embolization according to the VARC-3 criteria

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country
1	A.S.Z. Aalst	Aalst		Belgium
2	University Hospitals Leuven	Leuven		Belgium
3	Maastricht UMC	Maastricht	Limburg	Netherlands
4	Leiden University Medical Center	Leiden	South Holland	Netherlands
5	St. Antonius Hospital	Nieuwegein	Utrecht	Netherlands