Evaluating platelet activation in patients with heart support devices
Official title: Analysis of the Platelet Activity State in Patients Implanted With Ventricular Assist Device (VAD)
Run by Scientific Institute San Raffaele · NCT03255928 · Data updated 2026-11-12
This study is testing how well platelets work in patients with severe heart failure who are getting or have received a heart support device to see if it can help prevent complications.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Scientific Institute San Raffaele Academic / other |
| Locations | 1 site (Milan, MI) |
| Status | Recruiting |
| Started | June 29, 2017 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | May 15, 2025 |
| Trial ID | NCT03255928 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include consenting patients with end-stage heart failure who are candidates for or have received short-term or durable mechanical circulatory support devices.
✕Probably not a fit
Patients under 18 years old will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study focuses on patients with end-stage heart failure who are either candidates for or have received a mechanical circulatory support device, such as a Ventricular Assist Device (VAD). It aims to assess the patients' haemostatic and coagulation profiles, particularly platelet function, using innovative tests like the Platelet Activity State (PAS) assay and the Thrombin Generation Test (TGT). Measurements will be taken at various time points, including before device implantation, during hospitalization, and throughout long-term follow-up, to understand the dynamics of platelet function and its relation to thromboembolic and hemorrhagic complications. The findings may help identify therapeutic targets for improving patient outcomes.
Why it matters
Potential benefit: If successful, this study could lead to improved management of thromboembolic and hemorrhagic complications in patients with mechanical circulatory support devices.
How similar studies have gone: Other studies have explored platelet function in similar contexts, but this specific approach using PAS and TGT is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * All consenting patients candidates for short-term (Impella, ECMO) or durable (LVAD) mechanical circulatory support device implantation * All consenting patients that are implanted with short-term (Impella, ECMO) or durable (LVAD) mechanical circulatory support device Exclusion Criteria: \- Patients \< 18-years old
Where it's running
-
San Raffaele Scientifc Institute - Cardiothoracic Intensive Care Unit
Milan, Mi, Italy Recruiting
Study contacts
- Principal investigator: Filippo Consolo, PhD — San Raffaele Scientific Institute
- Study coordinator: Filippo Consolo, PhD
- Email: consolo.filippo@unisr.it
- Phone: +390226436153
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.