Evaluating platelet activation in patients with heart support devices
Analysis of the Platelet Activity State in Patients Implanted With Ventricular Assist Device (VAD)
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 |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Scientific Institute San Raffaele Academic / other |
| Locations | 1 site (Milan, MI) |
| Trial ID | NCT03255928 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients under 18 years old will not benefit from this study.
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 performed: Other studies have explored platelet function in similar contexts, but this specific approach using PAS and TGT is relatively novel.
Eligibility criteria
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 this trial is running
Milan, MI
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.