Study of Platelet Activity in Adults With Ventricular Assist Devices VAD Using Advanced Blood Tests
Led by Scientific Institute San Raffaele · Updated on 2025-05-15
60
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are investigating how the blood clotting and platelet function change in patients with end-stage heart failure who receive mechanical circulatory support devices such as percutaneous microaxial pumps Impella, extracorporeal membrane oxygenators ECMO, or Ventricular Assist Devices VAD. The study aims to understand how these devices interact with the bloods clotting system and antithrombotic drugs to identify causes of clotting or bleeding complications and potential treatment targets.
The study uses two innovative tests to evaluate platelet function the Platelet Activity State PAS assay and the Thrombin Generation Test TGT. These tests are performed at several points before device implantation to establish baseline values, early after implantation during hospital stay, throughout long-term follow-up, and when complications or therapy changes occur. Alongside these tests, standard blood parameters related to coagulation and hemolysis are measured, and device function data such as pump speed and power use are recorded.
Participants are monitored for up to 24 months with evaluations at 1, 3, 6, 12, 18, and 24 months after device implantation, as well as when any adverse events happen. Researchers track changes in platelet activity, coagulation markers, device parameters, and antithrombotic therapies. The study focuses on understanding how these factors relate to post-implant complications to improve patient care and device management.
CONDITIONS
Brief Title
Dynamics of Platelet Activation in Patients With Ventricular Assist Device (VAD)
Research Team
F
Filippo Consolo, PhD
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All consenting patients candidates for short-term (Impella, ECMO) or durable (LVAD) mechanical circulatory support device implantation
All consenting patients implanted with short-term (Impella, ECMO) or durable (LVAD) mechanical circulatory support device
Age between 18 and 75 years
You will not qualify if you...
Patients younger than 18 years old
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Up to 1 day before implant
Participants have platelet function evaluated using the Platelet Activity State (PAS) assay and the Thrombin Generation Test (TGT) before the ventricular assist device implant to define baseline characteristics.
1 baseline visit (in-person)
Implementation
Duration - During hospitalization post-implant
Participants undergo ventricular assist device implantation with platelet function and pump working parameters monitored during early post-implant hospitalization.
Approximately 1 to 2 visits during hospitalization
Long-term Monitoring
Duration - Up to 24 months post-implant
Participants are monitored for platelet function, coagulation parameters, pump working conditions, and antithrombotic therapy changes during long-term follow-up to evaluate dynamics over the course of support and after any complications.
Visits at 1, 3, 6, 12, 18, and 24 months post-implant and additional visits at occurrence of any adverse event
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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Study of Platelet Activity in Adults With Ventricular Assist Devices VAD Using Advanced Blood Tests
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Published Research Related To This Trial
Real-Time Analysis of the Log Files of the HeartWare Continuous-Flow Left Ventricular Assist Device for the Early Diagnosis of Pump Thrombosis: a Step Forward Toward Clinical Translation.
Shear-mediated platelet activation in patients implanted with continuous flow LVADs: A preliminary study utilizing the platelet activity state (PAS) assay.
Lorenzo Valerio, Filippo Consolo, Danny Bluestein...
Shear-mediated platelet activation in the free flow: Perspectives on the emerging spectrum of cell mechanobiological mechanisms mediating cardiovascular implant thrombosis.
Marvin J Slepian, Jawaad Sheriff, Marcus Hutchinson...
Acetylated prothrombin as a substrate in the measurement of the procoagulant activity of platelets: elimination of the feedback activation of platelets by thrombin.