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New study probes hidden blood risks in heart pump patients

NCT ID NCT06487091

Knowledge-focused Sponsor: Università Vita-Salute San Raffaele Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study examined how the Impella heart pump changes platelet function in 30 patients with cardiogenic shock or cardiac arrest. Researchers measured markers of platelet activation and aggregation before and during pump support. The goal was to understand why some patients develop serious complications like bleeding or clots, and to find ways to identify high-risk individuals early.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could help doctors identify patients at high risk of bleeding or clotting while on an Impella pump, leading to better monitoring and personalized treatments.
What could go wrong
This is a small, observational study with only 30 participants, so findings may not apply to all patients. It is exploratory and does not test a new treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

30 people

The number who actually took part.

Started

Feb 2025

Finished

Apr 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

cardiac arrest cardiogenic shock Hemorrhage Shock, Cardiogenic thrombotic disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cardiac arrest Cardiogenic shock Mechanical circulatory support

Contacts and locations

Locations

  • IRCCS San Raffaele Hospital

    Milan, 20132, Italy

  • Università Vita Salute San Raffaele

    Milan, 20132, Italy

More trials for these conditions

Other studies related to the condition(s) this trial covers.