Status:

RECRUITING

Platelet Function and Impella Support

Lead Sponsor:

Università Vita-Salute San Raffaele

Collaborating Sponsors:

Abiomed Inc.

Conditions:

Cardiogenic Shock

Cardiac Arrest

Eligibility:

All Genders

18-75 years

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, i...

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...

Eligibility Criteria

Inclusion

  • 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

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

Key Trial Info

Start Date :

February 24 2025

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

January 31 2027

Estimated Enrollment :

30 Patients enrolled

Trial Details

Trial ID

NCT06487091

Start Date

February 24 2025

End Date

January 31 2027

Last Update

April 13 2025

Active Locations (2)

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Page 1 of 1 (2 locations)

1

IRCCS San Raffaele Hospital

Milan, Italy, 20132

2

Università Vita Salute San Raffaele

Milan, Italy, 20132