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

Status

Completed

Phases

Phase 3Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-504205-36-00

Acronym

2023-504205-36-00

Enrollment

800

Registered

2023-06-13

Start date

2023-11-01

Completion date

2026-01-02

Last updated

2025-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic stenosis

Brief summary

The composite of cardiovascular mortality or clinically relevant bleeding (VARC-3 type 1-4) within 30 days after TAVI procedure.

Detailed description

All bleeding (VARC-3 type 1-4), Major, life-threatening or fatal bleeding (VARC-3 type 2-4), Major vascular complications (VARC-3), Cardiovascular mortality (VARC-3), All-cause mortality

Interventions

DRUGProtamine sulfaat LEO Pharma 1400 anti-heparine IE/ml oplossing voor injectie en infusie

DRUGNaCl 0

DRUG9 % B. Braun

DRUGoplossing voor infusie

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The composite of cardiovascular mortality or clinically relevant bleeding (VARC-3 type 1-4) within 30 days after TAVI procedure.	—

Secondary

Measure	Time frame
All bleeding (VARC-3 type 1-4), Major, life-threatening or fatal bleeding (VARC-3 type 2-4), Major vascular complications (VARC-3), Cardiovascular mortality (VARC-3), All-cause mortality	—

Countries

Belgium, Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026