Actively Recruiting
Analysis of the Platelet Activity State in Patients Implanted With Ventricular Assist Device VAD
Led by Scientific Institute San Raffaele · Updated on 2025-05-15
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
S
Scientific Institute San Raffaele
Lead Sponsor
U
Università Vita-Salute San Raffaele
Collaborating Sponsor
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
Research Team
F
Filippo Consolo, PhD
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