Antagonization of Heparin With Protamine Sulfate After TAVI
- Conditions
- Aortic Valve StenosisHeart Valve Diseases
- Registration Number
- NCT06215378
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- 940
Inclusion Criteria:<br><br> - Men and women =18 years of age<br><br> - Any patient eligible for transfemoral TAVI, irrespective of the chronic<br> antithrombotic treatment<br><br> - Written informed consent<br><br> - Registered at the French social healthcare<br><br>Exclusion Criteria:<br><br> - Any major protamine sulfate exposure contraindications defined as a history of<br> severe pulmonary hypertension, acute pulmonary edema or history of bronchospasm<br> related to protamine sulfate administration<br><br> - Known allergy to protamine sulfate<br><br> - Hypersensitivity to protamine sulfate including protamine contained as an excipient<br> in NPH [Neutral Protamine Hagedorn] insulin, known protamine or protamine-heparine<br> complex antibodies<br><br> - Non-femoral approach for the TAVI procedure<br><br> - Protamine sulfate exposure within 24h of randomization<br><br> - Fish allergy<br><br> - Mechanical valves<br><br> - For men: Sterile or Vasectomy<br><br> - Women of childbearing potential<br><br> - Pregnancy and breast feeding women<br><br> - Contemporaneous enrolment in an interventional clinical trial<br><br> - Patient under guardianship or curatorship
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Composite of ischemic and bleeding events
- Secondary Outcome Measures
Name Time Method In hospital stay;Bleeding complication;Assessement of interaction;Assessement of adverse outcome;Assessement of long term adverse outcome