Hemostatic Profiling to Enable Personalized Antithrombotic Therapy in Patients After Transcatheter Aortic Valve Replacement

Hemostatic Profiling to Enable Personalized Antithrombotic Therapy in Patients After Transcatheter Aortic Valve Replacement - HEMOSTAVR

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00029969

Enrollment

103

Registered

2022-08-17

Start date

2022-09-02

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

I35.0 I64 I21

Interventions

Group 1: Patients undergoing TAVR during current hospitalization

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: • Scheduled for TAVR during current hospitalisation (per standard of care) • Informed consent • Age =18 years

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
leaflet thrombosis, all-cause mortality, myocardial infarction, or stroke/transient ischemic attack at 6 months after TAVR	—

Secondary

Measure	Time frame
1. Bleedings (major or non-major clinically relevant) as defined by the International Society on Thrombosis and Haemostasis (ISTH) after 180 days. 2. Assessment of other exploratory markers: o Immature platelet fraction o CYP2C19 genotyping o Antiphospholipid antibodies (Lupus-Anticoagulant, Cardiolipin Antibody, Anti-beta-2-Glycoprotein I) o Anti-Factor Xa/II activity o Light transmittance aggregometry o Thrombelastography (TEG®) o Clot Pro® o Soluble hemostatic (bio)markers o Cell based hemostatic (bio)markers	—

Measure

Time frame

1. Bleedings (major or non-major clinically relevant) as defined by the International Society on Thrombosis and Haemostasis (ISTH) after 180 days. 2. Assessment of other exploratory markers: o Immature platelet fraction o CYP2C19 genotyping o Antiphospholipid antibodies (Lupus-Anticoagulant, Cardiolipin Antibody, Anti-beta-2-Glycoprotein I) o Anti-Factor Xa/II activity o Light transmittance aggregometry o Thrombelastography (TEG®) o Clot Pro® o Soluble hemostatic (bio)markers o Cell based hemostatic (bio)markers

—

Countries

Germany

Contacts

Public ContactDavid Hesselbarth

Universitätsklinikum Freiburg, Kardiologie und Angiologie I

David.hesselbarth@uniklinik-freiburg.de076127034010

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026