Hemostatic Profiling to Enable Personalized Antithrombotic Therapy in Patients After Transcatheter Aortic Valve Replacement
Recruiting
- Conditions
- I35.0I64I21Aortic (valve) stenosisStroke, not specified as haemorrhage or infarctionAcute myocardial infarction
- Registration Number
- DRKS00029969
- Lead Sponsor
- niversitätsklinikum Freiburg, Kardiologie und Angiologie I
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 103
Inclusion Criteria
• Scheduled for TAVR during current hospitalisation (per standard of care)
• Informed consent
• Age =18 years
Exclusion Criteria
Severe renal insufficiency (GFR<30ml/min)
• Any other condition as determined by the PI. (e.g. incompliance, drug abuse, unwillingness to adhere to the protocol)
• Less than 50 thousand platelets per µl blood
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method leaflet thrombosis, all-cause mortality, myocardial infarction, or stroke/transient ischemic attack at 6 months after TAVR
- Secondary Outcome Measures
Name Time Method 1. Bleedings (major or non-major clinically relevant) as defined by the International Society on Thrombosis and Haemostasis (ISTH) after 180 days.<br><br>2. Assessment of other exploratory markers:<br>o Immature platelet fraction <br>o CYP2C19 genotyping<br>o Antiphospholipid antibodies (Lupus-Anticoagulant, Cardiolipin Antibody, Anti-beta-2-Glycoprotein I)<br>o Anti-Factor Xa/II activity<br>o Light transmittance aggregometry<br>o Thrombelastography (TEG®)<br>o Clot Pro®<br>o Soluble hemostatic (bio)markers<br>o Cell based hemostatic (bio)markers