trombosevorming op kunstmateriaal in de bloedcirculatie medical device-induced thrombosis / clot formation on medical devices
Conditions
Interventions
None listed
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
Exclusion criteria: - Documented history of clotting disorders - Incapacitated patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint: To evaluate if there is a significant difference in the levels of coagulation markers associated with contact activation on blood-contacting medical devices before and after implantation of LVADs. - ELISA: Markers of contact system activation: Cleaved High molecular weight kininogen (cHK), complexes of the protease inhibitor C1-inhibitor and components of the contact system (i.e. Plasma-kallikrein; FXIIa; FXIa) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoint: To evaluate if there is a significant difference in the levels of markers for primary and secondary hemostasis involved in coagulation on blood-contacting medical devices before and after implantation of biological heart valves or LVADs. - FACS: Platelet activation: P-selectin expression and binding of fibrinogen to the fibrinogenreceptor aIIbβ3 - ELISA: Markers of systemic platelet activation: soluble P-selectin, b-TG, PF4, aVWF Markers of active coagulation: D-dimer, Thrombin-antithrombin complexes, prothrombin fragment 1+2. Elastase-a1-antitrypsin complexes, nucleosomes | — |
Countries
Netherlands
Outcome results
None listed