Analyzing Platelet Function in Patients with Impella Support
Analysis of Platelet Function During Impella Support
This study is testing how the Impella heart device affects blood platelets in patients with severe heart problems to see if it can help identify risks for complications.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Università Vita-Salute San Raffaele Academic / other |
| Locations | 2 sites (Milano and 1 other locations) |
| Trial ID | NCT06487091 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate changes in platelet function in patients experiencing cardiogenic shock or cardiac arrest who are receiving support from the Impella device. It will analyze specific markers of platelet activation and aggregation to identify potential risks for adverse events such as thrombotic or hemorrhagic complications. The study will involve collecting platelet samples from participants to assess changes over time, driven by the mechanical forces exerted by the Impella pump. The goal is to establish a platelet function profile that could help stratify patients based on their risk levels.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 75 who are experiencing cardiogenic shock classified as SCAI class C-D-E and are receiving primary mechanical circulatory support with an Impella device.
Not a fit: Patients younger than 18 or older than 75, as well as those who refuse to participate, will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved risk stratification and management of patients receiving Impella support, potentially reducing complications.
How similar studies have performed: While previous studies have explored platelet function in durable mechanical circulatory support, this specific approach with the Impella device is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients \>18yrs-old and \<75yrs-old * Cardiogenic shock SCAI class C-D-E * primary tMCS with an Impella device (all Impella pumps) * Informed consent Exclusion Criteria: * Patients \<18yrs-old or \>75yrs-old * Refusal to participate to the study
Where this trial is running
Milano and 1 other locations
- IRCCS San Raffaele Hospital — Milano, Italy (Recruiting)
- Università Vita Salute San Raffaele — Milano, Italy (Recruiting)
Study contacts
- Principal investigator: Mara Scandroglio, MD — Ospedale San Raffaele
- 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.