Platelet Function and Impella Support

NCT06487091 | Completed FDA Device

• 1 other identifier: IMPELLA-PLT
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Cardiogenic Shock; Cardiac Arrest; Mechanical Circulatory Support

Keywords

Cardiogenic Shock; Cardiac Arrest; Mechanical Circulatory Support; Impella; Platelet Function; Bleeding; Thrombosis; Hemolyisis; platelet microRNA

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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]

  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

  12 hours after any change in the antithrombotic regimen

Study Arms (1)

patients on Impella support

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

Diagnostic Test: Analysis of platelet function

Interventions

Analysis of platelet function DIAGNOSTIC_TEST

Blood withdrawal, platelet separation and analysis of the expression levels of markers of platelet function

patients on Impella support

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Patients \>18yrs-old and \<75yrs-old
• Cardiogenic shock SCAI class C-D-E
• primary tMCS with an Impella device (all Impella pumps)
• Informed consent

You may not qualify if:

• Patients \<18yrs-old or \>75yrs-old
• Refusal to participate to the study

Sponsors & Collaborators

• Università Vita-Salute San Raffaele: lead
• Abiomed Inc.: collaborator

Study Sites (2)

IRCCS San Raffaele Hospital

Milan, 20132, Italy

Location

Università Vita Salute San Raffaele

Milan, 20132, Italy

Location

Related Publications (8)

• Chen Z, Mondal NK, Ding J, Gao J, Griffith BP, Wu ZJ. Shear-induced platelet receptor shedding by non-physiological high shear stress with short exposure time: glycoprotein Ibalpha and glycoprotein VI. Thromb Res. 2015 Apr;135(4):692-8. doi: 10.1016/j.thromres.2015.01.030. Epub 2015 Feb 7.

  PMID: 25677981 BACKGROUND

• Klaeske K, Dieterlen MT, Eifert S, Scholz U, Garbade J, Jawad K, Sieg F, Borger MA, Meyer AL. Device-induced platelet dysfunction in patients after left ventricular assist device implantation. J Thromb Haemost. 2021 May;19(5):1331-1341. doi: 10.1111/jth.15279. Epub 2021 Mar 28.

  PMID: 33636040 BACKGROUND

• Arias K, Sun W, Wang S, Sorensen EN, Feller E, Kaczorowski D, Griffith B, Wu ZJ. Acquired platelet defects are responsible for nonsurgical bleeding in left ventricular assist device recipients. Artif Organs. 2022 Nov;46(11):2244-2256. doi: 10.1111/aor.14319. Epub 2022 May 30.

  PMID: 35596611 BACKGROUND

• Klaeske K, Meyer AL, Saeed D, Eifert S, Jawad K, Sieg F, Haunschild J, Borger MA, Dieterlen MT. Decreased Platelet Specific Receptor Expression of P-Selectin and GPIIb/IIIa Predict Future Non-Surgical Bleeding in Patients after Left Ventricular Assist Device Implantation. Int J Mol Sci. 2022 Sep 6;23(18):10252. doi: 10.3390/ijms231810252.

  PMID: 36142161 BACKGROUND

• Lombardi M, Bonora M, Baldetti L, Pieri M, Scandroglio AM, Landoni G, Zangrillo A, Foglieni C, Consolo F. Left ventricular assist devices promote changes in the expression levels of platelet microRNAs. Front Cardiovasc Med. 2023 Jun 15;10:1178556. doi: 10.3389/fcvm.2023.1178556. eCollection 2023.

  PMID: 37396581 BACKGROUND

• Bernhardt AM, Copeland H, Deswal A, Gluck J, Givertz MM; Chairs:; Co-Chairs:; Contributing Writers:; Chair:; Co-Chair:; Contributing Writers:; Chair:; Co-Chairs:; Contributing Writers:; Chair:; Co-Chair:; Contributing Writers:. The International Society for Heart and Lung Transplantation/Heart Failure Society of America Guideline on Acute Mechanical Circulatory Support. J Heart Lung Transplant. 2023 Apr;42(4):e1-e64. doi: 10.1016/j.healun.2022.10.028. Epub 2023 Feb 6. No abstract available.

  PMID: 36805198 BACKGROUND

• Garcia-Garcia HM, McFadden EP, Farb A, Mehran R, Stone GW, Spertus J, Onuma Y, Morel MA, van Es GA, Zuckerman B, Fearon WF, Taggart D, Kappetein AP, Krucoff MW, Vranckx P, Windecker S, Cutlip D, Serruys PW; Academic Research Consortium. Standardized End Point Definitions for Coronary Intervention Trials: The Academic Research Consortium-2 Consensus Document. Circulation. 2018 Jun 12;137(24):2635-2650. doi: 10.1161/CIRCULATIONAHA.117.029289.

  PMID: 29891620 BACKGROUND

• Kormos RL, Antonides CFJ, Goldstein DJ, Cowger JA, Starling RC, Kirklin JK, Rame JE, Rosenthal D, Mooney ML, Caliskan K, Messe SR, Teuteberg JJ, Mohacsi P, Slaughter MS, Potapov EV, Rao V, Schima H, Stehlik J, Joseph S, Koenig SC, Pagani FD. Updated definitions of adverse events for trials and registries of mechanical circulatory support: A consensus statement of the mechanical circulatory support academic research consortium. J Heart Lung Transplant. 2020 Aug;39(8):735-750. doi: 10.1016/j.healun.2020.03.010. Epub 2020 Apr 18. No abstract available.

  PMID: 32386998 BACKGROUND

MeSH Terms

Conditions

Shock, Cardiogenic; Heart Arrest; Hemorrhage; Thrombosis

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock; Embolism and Thrombosis

Study Officials

• Filippo Consolo, PhD

  Università Vita-Salute San Raffaele

  STUDY CHAIR

• Mara Scandroglio, MD

  Ospedale San Raffaele

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 31, 2024
• First Posted: July 5, 2024
• Study Start: February 24, 2025
• Primary Completion: April 10, 2026
• Study Completion: April 10, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)