Routine versus selective protamine administration to reduce bleeding complications after transcatheter aortic valve implantatio

Phase 1

Recruiting

• Conditions: Aortic stenosis; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02]

• Registration Number: CTIS2023-504205-36-00
• Lead Sponsor: St Antonius Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-23
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 800

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 clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine the effect of routine protamine administration, compared with selective protamine administration, on the risk of cardiovascular mortality or type 1-4 bleeding within 30 days after TAVI according to VARC-3 criteria.;Secondary Objective: Post-procedural haemoglobin level, Procedural haemostasis failure, Delayed haemostasis failure, The need for transfusion, The length of post-procedural stay, The risk of all bleeding (VARC-3 type 1-4), The risk of major bleeding, life-threatening or fatal bleeding (VARC-3 type 2-4), The risk of major vascular complications (VARC-3), The risk of cardiovascular mortality (VARC-3), The risk of all-cause mortality (VARC-3);Primary end point(s): The composite of cardiovascular mortality or type 1-4 bleeding within 30 days after TAVI according to VARC-3 criteria

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):Haemoglobin level;Secondary end point(s):Procedural haemostasis failure;Secondary end point(s):Delayed haemostasis failure;Secondary end point(s):Length of post-procedural stay;Secondary end point(s):Need for transfusion;Secondary end point(s):All bleeding (VARC-3 type 1-4);Secondary end point(s):Major, life-threatening or fatal bleeding (VARC-3 type 2-4);Secondary end point(s):Major vascular complications (VARC-3);Secondary end point(s):Cardiovascular mortality (VARC-3);Secondary end point(s):All-cause mortality