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

Study Overview
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Brief Summary
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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.

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

Conditions
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Aortic Valve Stenosis

Intervention / Treatment
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* Drug: Protamine sulfate
* Drug: Protamine sulfate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Routine protamine administration<br>Routine protamine administration in a ratio of 1 mg per 100 IU of unfractionated heparin. | Drug: Protamine sulfate<br>* Routine protamine administration in a ratio of 1 mg per 100 IU of unfractionated heparin<br>* Other names: Routine heparin reversal;|
| Active Comparator: Selective protamine administration<br>Selective protamine administration, in case of (threatening) bleeding. | Drug: Protamine sulfate<br>* Selective protamine administration, in case of (threatening) bleeding<br>* Other names: Selective heparin reversal;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of cardiovascular mortality or type 1-4 bleeding | According to the VARC-3 criteria | 30 days after TAVI | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Haemoglobin level | mmol/L | 30 days after TAVI | 
| 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 | 
| 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 | 
| 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 | 
| Need for transfusion | Any bleeding requiring transfusion of 1 or more units of whole blood/RBC | 30 days after TAVI | 
| All bleeding | According to the VARC-3 criteria type 1-4 bleeding | 30 days after TAVI | 
| Major, life-threatening or fatal bleeding | According to the VARC-3 criteria type 2-4 bleeding | 30 days after TAVI | 
| Major vascular complications | According to the VARC-3 criteria | 30 days after TAVI | 
| Cardiovascular mortality | According to the VARC-3 criteria | 30 days after TAVI | 
| All-cause mortality | According to the VARC-3 criteria | 30 days after TAVI | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TAVI, TAVR, Bleeding, Mortality, Allergy, Protamine