Platelet Function and Impella Support
NCT Number: NCT06487091
Acronym: IMPELLA-PLT
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Cardiogenic Shock|Cardiac Arrest|Mechanical Circulatory Support
Interventions: DIAGNOSTIC_TEST: Analysis of platelet function
Sponsor: Università Vita-Salute San Raffaele
Collaborators: Ospedale San Raffaele
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2026-12-31
Locations: Università Vita Salute San Raffaele, Milano, 20132, Italy

Summary:
Mechanical circulatory support (MCS) with the Impella microaxial pump in the setting of cardiogenic shock/cardiac arrest (CS/CA) is accompanied by substantial risk of life-threatening complications, including hemolysis, thrombotic and bleeding events.

Previous studies in patients on durable MCS suggest that device-induced platelet dysfunction plays a major contributory role in the development of such events and that selected markers of platelet function have the potential to stratify patients according to an elevated risk of adverse events. To date, the potential clinical utility of markers of altered platelet function in patients supported with an Impella pump is unexplored.

The proposed study will analyze changes in platelet function in the setting of Impella support (primary aim) and possibly identify a platelet function "profile" indicative of patients at high-risk to develop adverse events (secondary aim).

The study is a prospective observational study. Changes in the expression levels of markers of both platelet activation and aggregation in patients supported with an Impella pump will be measured. Data will be longitudinally measured: pre-implant (before Impella implantation) and then after 24, 48 and 72h of Impella support. Markers that will be analyzed include surface platelet receptors and platelet microRNAs. Experimental data will be correlated with clinical outcomes, including the occurrence of adverse events.

This study will provide mechanistic insights into the effect of Impella support on the protein and miRNA expression of platelets. The intention is to get a better understanding of distinct pathways of platelet function related to Impella support and their relationship to adverse events. Our data might open the perspective for the future clinical use of markers of platelet function to enhance the early recognition of patients at high risk of developing an adverse event and the definition of novel, personalized therapeutic strategies targeted to platelet biology to prevent their occurrence.

Primary Outcome Measures: Expression levels of platelet surface markers of activation and aggregation and platelet microRNAs in patients on Impella support, Changes (measured as percentage variation) in the expression levels of platelet surface markers of activation and aggregation (GPIba, GPIIb/IIIa, and GPVI) and platelet microRNA (miR-20b-5p, miR-25-3p, miR-126-5p, miR-451a, miR-320a, miR-223-3p, miR-144-rp, miR-151a-3p, and miR-454-3p) during tMCS with an Impella device (all Impella pumps), baseline (prior to Impella implantation) vs. 24 hours, 48 hours and 72 hours of Impella support
Secondary Outcome Measures: Expression levels of platelet surface markers of activation and aggregation and platelet microRNAs in the acute phase of an adverse event (hemolysis, thrombosis, bleeding). Adverse events will be determined according to [6-8], Expression levels of platelet surface markers of activation and aggregation (GPIba, GPIIb/IIIa, and GPVI) and platelet microRNA (miR-20b-5p, miR-25-3p, miR-126-5p, miR-451a, miR-320a, miR-223-3p, miR-144-rp, miR-151a-3p, and miR-454-3p) measured following the occurrence of an adverse event (hemolysis, thrombosis, bleeding), immediately after any adverse event, anticipated average 30 days|Expression levels of platelet surface markers of activation and aggregation and platelet microRNAs after any change in the antithrombotic regimen, Expression levels of platelet surface markers of activation and aggregation (GPIba, GPIIb/IIIa, and GPVI) and platelet microRNA (miR-20b-5p, miR-25-3p, miR-126-5p, miR-451a, miR-320a, miR-223-3p, miR-144-rp, miR-151a-3p, and miR-454-3p) measured following any change in the antithrombotic regimen (lower dose and/or withdrawal of anticoagulant/antiplatelet drugs), 12 hours after any change in the antithrombotic regimen