Platelet Function and Impella Support (IMPELLA-PLT)

April 28, 2026 updated by: Filippo Consolo, Università Vita-Salute San Raffaele

Analysis of Platelet Function During Impella Support

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

STUDY DESIGN AND MAIN OBJECTIVE Prospective observational study to evaluate changes in the expression levels of markers of platelet function (activation and aggregation capacity) in CS/CA patients who receive an Impella device for temporary mechanical circulatory support

HYPOTHESIS

  • progressive change of platelet function occurs over the course of Impella support driven by shear forces exerted by the pump on recirculating blood
  • markers of changes in platelet function can be identified at the protein and nuclear level in platelet samples extracted form patients supported with an Impella pump
  • specific trends of the changes of the expression levels of markers of platelet function might allow identifying patients at higher risk of developing a thrombotic/hemorrhagic complication
  • the expression levels of markers of platelet function are indeed altered in patients even before the clinical manifestation of the event

METHODOLOGY The markers that will be analyzed have been selected according to recent studies showing

  • significant changes in their expression levels driven by durable MCS devices
  • their potential to identify patients at high risk of developing adverse events
  • their association with coagulation/hemostatic disorders and hemolysis and include:
  • platelet receptors GPIba, GPIIb/IIIa, and GPVI [1-4].
  • 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 [5]. The expression levels of these microRNAs will be measured in both PRP and PPP samples, to confirm their actual expression by platelets.

Data will be measured

  • pre-implant (i.e., immediately prior to Impella implantation), to evaluate the patient-specific baseline profile, and then following
  • 24 hours, 48 hours, and 72 hours of Impella support. This way it will possible to quantify longitudinal changes in the levels of expression of the selected markers over the course of Impella support (vs. baseline).

Data will be also measured during the acute phase of any of the following adverse events that will occur during Impella support (not limited to 72 hours):

  • thrombosis (of the patient - any site - and of the pump)
  • ischemic/hemorrhagic stroke
  • any surgical or non-surgical bleeding
  • hemolysis Adverse events will be defined according to most recent criteria [6-8].

Furthermore, inferences of any change in the anticaogulation regimen that may occur over the course of Impella support (not limited to 72 hours) will be evaluated: to this aim, markers of platelet function will be analyzed 12 hours following any change in the anticoagulation regimen.

Experimental data will be correlated with clinical outcomes, including the occurrence of adverse events, to possibly identify an "event-related platelet function profile" characteristics of the sub-group of patients that will develop adverse events. The occurrence of adverse events will be continuously recorded over the whole duration of Impella support.

TREATMENT PROCEDURE To measure the expression levels of the selected markers of platelet function, platelet samples will be isolated from patients' blood (10-mL volume) via standard laboratory techniques. The expression levels of the analyzed markers will be measured via quantitative real-time polymerase chain reaction and protein quantitation/function assay, such as enzyme-linked immunosorbent assay.

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy, 20132
        • IRCCS San Raffaele Hospital
      • Milan, Italy, 20132
        • Università Vita Salute San Raffaele

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

CS/CA patients who receive temporary mechanical circulatory support with an Impella device

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients on Impella support
CS/CA patients that receive primary temporary mechanical circulatory support with an Impella device
Diagnostic test: Analysis of platelet function
Blood withdrawal, platelet separation and analysis of the expression levels of markers of platelet function

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Expression levels of platelet surface markers of activation and aggregation and platelet microRNAs in patients on Impella support
Time Frame: baseline (prior to Impella implantation) vs. 24 hours, 48 hours and 72 hours of 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

Outcome Measure
Measure Description
Time Frame
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]
Time Frame: immediately after any adverse event, anticipated average 30 days
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
Time Frame: 12 hours 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Università Vita-Salute San Raffaele

Collaborators

Abiomed Inc.

Investigators

  • Study Chair: Filippo Consolo, PhD, Università Vita-Salute San Raffaele
  • Principal Investigator: Mara Scandroglio, MD, Ospedale San Raffaele

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 24, 2025

Primary Completion (Actual)

April 10, 2026

Study Completion (Actual)

April 10, 2026

Study Registration Dates

First Submitted

May 31, 2024

First Submitted That Met QC Criteria

July 1, 2024

First Posted (Actual)

July 5, 2024

Study Record Updates

Last Update Posted (Actual)

May 5, 2026

Last Update Submitted That Met QC Criteria

April 28, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMPELLA-PLT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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