Prospective monocenter cohort study for evaluation of contact activation in patients with implanted cardiovascular devices

Completed

• Conditions: trombosevorming op kunstmateriaal in de bloedcirculatie; medical device-induced thrombosis / clot formation on medical devices

• Registration Number: NL-OMON55375
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 90

Inclusion Criteria

- Age 18 years and older
- Will undergo an elective or urgent biological heart valve replacement or
Left Ventriucal Assist Device implantation

Exclusion Criteria

- Documented history of clotting disorders
- Incapacitated patients

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint: To evaluate if there is a significant difference in the<br /><br>levels of coagulation markers associated with contact activation on<br /><br>blood-contacting medical devices before and after implantation of LVADs.<br /><br>- ELISA:<br /><br>Markers of contact system activation: Cleaved High molecular weight kininogen<br /><br>(cHK), complexes of the protease inhibitor C1-inhibitor and components of the<br /><br>contact system (i.e. Plasma-kallikrein; FXIIa; FXIa)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoint: To evaluate if there is a significant difference in the<br /><br>levels of markers for primary and secondary hemostasis involved in coagulation<br /><br>on blood-contacting medical devices before and after implantation of biological<br /><br>heart valves or LVADs.<br /><br>- FACS:<br /><br>Platelet activation: P-selectin expression and binding of fibrinogen to the<br /><br>fibrinogenreceptor aIIb&beta;3<br /><br>- ELISA:<br /><br>Markers of systemic platelet activation: soluble P-selectin, b-TG, PF4, aVWF<br /><br>Markers of active coagulation: D-dimer, Thrombin-antithrombin complexes,<br /><br>prothrombin fragment 1+2.<br /><br>Elastase-a1-antitrypsin complexes, nucleosomes</p><br>