Clinical trial NCT05774691: Routine Versus Selective Protamine Administration to Reduce Bleeding Complications After Transcatheter Aortic Valve Implantation (POPular ACE TAVI)
Official title: Routine Versus Selective Protamine Administration to Reduce Bleeding Complications After Transcatheter Aortic Valve Implantation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Aortic Valve Stenosis
Keywords: TAVI
TAVR
Bleeding
Mortality
Allergy
Protamine
Lead sponsor: St. Antonius Hospital
Sponsor class: OTHER
Collaborators: name: St. Antonius Research Fund
First posted: 2023-03-20
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Composite of cardiovascular mortality or type 1-4 bleeding
timeFrame: 30 days after TAVI
Secondary outcomes:
measure: Haemoglobin level
timeFrame: 30 days after TAVI
measure: Procedural haemostasis failure
timeFrame: 30 days after TAVI
measure: Delayed haemostasis failure
timeFrame: 30 days after TAVI
measure: Length of post-procedural stay
timeFrame: 30 days after TAVI
measure: Need for transfusion
timeFrame: 30 days after TAVI
measure: All bleeding
timeFrame: 30 days after TAVI
measure: Major, life-threatening or fatal bleeding
timeFrame: 30 days after TAVI
measure: Major vascular complications
timeFrame: 30 days after TAVI
measure: Cardiovascular mortality
timeFrame: 30 days after TAVI
measure: All-cause mortality
timeFrame: 30 days after TAVI
Other outcomes:
measure: Anaphylaxis
timeFrame: 30 days after TAVI
measure: Thromboembolic events
timeFrame: 30 days after TAVI
Locations:
city: Aalst
country: Belgium
facility: A.S.Z. Aalst
city: Leuven
country: Belgium
facility: University Hospitals Leuven
city: Maastricht
country: Netherlands
facility: Maastricht UMC
state: Limburg
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
state: South Holland
city: Nieuwegein
country: Netherlands
facility: St. Antonius Hospital
state: Utrecht
city: Amsterdam
country: Netherlands
facility: Amsterdam University Medical Center
Study officials:
References: