Antagonization of Heparin With Protamine Sulfate After TAVI

PHASE3RecruitingINTERVENTIONAL
Enrollment

940

Participants

Timeline

Start Date

May 25, 2025

Primary Completion Date

March 1, 2027

Study Completion Date

March 1, 2027

Conditions
Aortic Valve StenosisHeart Valve Diseases
Interventions
DRUG

Antagonization of heparin with protamine sulfate

A systematic use at the end of procedure of Protamine Sulfate for antagonization of heparine.1 mg of protamine sulfate neutralizes approximately 100 heparin unit. To be administered in slow infusion (10 min) not exceeding 50mg of protamine sulfate to reverse 100% of the anti-IIa activity of heparin sodium. If the ACT is not back to the baseline value after the end of this infusion, additional doses of protamine should be performed depending on the ACT value to obtain complete antagonization of anti-IIa activity of heparin sodium

Trial Locations (1)

75013

RECRUITING

Pitié Salpêtrière hospital, Paris

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Action Research Group

OTHER

lead

Assistance Publique - Hôpitaux de Paris

OTHER