Clinical trial Recruiting at 1 site Observational Ages 18 to 75

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 typeObservational
Ages18 Years to 75 Years
SexAll
Enrollment60 (estimated)
SponsorScientific Institute San Raffaele
Academic / other
Locations1 site (Milan, MI)
StatusRecruiting
StartedJune 29, 2017
Main results expectedDecember 31, 2026
Study endsDecember 31, 2026
Registry record updatedMay 15, 2025
Trial IDNCT03255928 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.