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...
https://pubmed.ncbi.nlm.nih.gov/26736495Actively Recruiting
Age: 18Years - 75Years
All Genders
Healthy Volunteers
ID03255928
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 blood's 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
Age: 18Years - 75Years
All Genders
Healthy Volunteers
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
AI-Screening
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1
2
3
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
Trial Site Locations
Total: 1 location
1
San Raffaele Scientifc Institute - Cardiothoracic Intensive Care Unit
Milan, MI, Italy, 20132
Actively Recruiting
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Research Team
F
Filippo Consolo, PhD
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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Published Research Related To This Trial
High Frequency Components of Hemodynamic Shear Stress Profiles are a Major Determinant of Shear-Mediated Platelet Activation in Therapeutic Blood Recirculating Devices.
Filippo Consolo, Jawaad Sheriff, Silvia Gorla...
https://pubmed.ncbi.nlm.nih.gov/28694489Comparative efficacy of in vitro and in vivo metabolized aspirin in the DeBakey ventricular assist device.
Jawaad Sheriff, Gaurav Girdhar, Wei-Che Chiu...
https://pubmed.ncbi.nlm.nih.gov/24043375High-shear stress sensitizes platelets to subsequent low-shear conditions.
Jawaad Sheriff, Danny Bluestein, Gaurav Girdhar...
https://pubmed.ncbi.nlm.nih.gov/20135353Acetylated prothrombin as a substrate in the measurement of the procoagulant activity of platelets: elimination of the feedback activation of platelets by thrombin.
J Jesty, D Bluestein
https://pubmed.ncbi.nlm.nih.gov/10405294Shear-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...
https://pubmed.ncbi.nlm.nih.gov/27887727Intrapericardial Left Ventricular Assist Device for Advanced Heart Failure.
Joseph G Rogers, Francis D Pagani, Antone J Tatooles...
https://pubmed.ncbi.nlm.nih.gov/28146651HeartWare ventricular assist system for bridge to transplant: combined results of the bridge to transplant and continued access protocol trial.
Mark S Slaughter, Francis D Pagani, Edwin C McGee...
https://pubmed.ncbi.nlm.nih.gov/23796152Aspirin has limited ability to modulate shear-mediated platelet activation associated with elevated shear stress of ventricular assist devices.
Lorenzo Valerio, Phat L Tran, Jawaad Sheriff...
https://pubmed.ncbi.nlm.nih.gov/26938158Platelet activation is a preoperative risk factor for the development of thromboembolic complications in patients with continuous-flow left ventricular assist device.
Filippo Consolo, Giulia Sferrazza, Giulia Motolone...
https://pubmed.ncbi.nlm.nih.gov/29282819