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

Phase 4

Recruiting

• Conditions: Aortic Valve Stenosis
• Interventions: Drug: Protamine sulfate

• Registration Number: NCT05774691
• Lead Sponsor: St. Antonius Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-03
• Study First Submitted QC: 2023-03-15
• Study First Posted: 2023-03-20
• Study Start: 2023-11-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-30
• Last Update Posted: 2024-05-31
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Routine protamine administration	Protamine sulfate	Routine protamine administration in a ratio of 1 mg per 100 IU of unfractionated heparin.
Selective protamine administration	Protamine sulfate	Selective protamine administration, in case of (threatening) bleeding.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
All bleeding	30 days after TAVI	According to the VARC-3 criteria type 1-4 bleeding
All-cause mortality	30 days after TAVI	According to the VARC-3 criteria
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
Major vascular complications	30 days after TAVI	According to the VARC-3 criteria
Major, life-threatening or fatal bleeding	30 days after TAVI	According to the VARC-3 criteria type 2-4 bleeding
Cardiovascular mortality	30 days after TAVI	According to the VARC-3 criteria

Trial Locations

Locations (6)

Amsterdam University Medical Center; 🇳🇱 Amsterdam, Netherlands

A.S.Z. Aalst; 🇧🇪 Aalst, Belgium

University Hospitals Leuven; 🇧🇪 Leuven, Belgium

St. Antonius Hospital; 🇳🇱 Nieuwegein, Utrecht, Netherlands

Maastricht UMC; 🇳🇱 Maastricht, Limburg, Netherlands

Leiden University Medical Center; 🇳🇱 Leiden, South Holland, Netherlands