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Balloon pump may boost ECMO success in shock patients

NCT ID NCT05913622

Disease control Sponsor: Erasmus Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether adding an intra-aortic balloon pump (IABP) to standard ECMO support helps more people with severe cardiogenic shock recover enough to come off the heart-lung machine. About 430 adults will be randomly assigned to get ECMO alone or ECMO plus IABP. The main goal is to see who can be weaned from ECMO within 30 days without needing a heart transplant or permanent heart pump.

What this could mean

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

Active substance
Intra-aortic balloon pump (IABP)
What this could lead to
If it works, this could show that adding an IABP helps more patients successfully come off ECMO without needing a heart transplant or long-term heart pump.
What could go wrong
This is an early-stage platform trial, so results may not be definitive. The IABP itself carries risks like bleeding or vessel damage, and the benefit over ECMO alone is unproven.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 430 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2023

Expected to finish

Jun 2028

An estimate. End dates often move.

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.

Ages

18 years and older

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 for the registry backbone: * Having received ECMO support for severe circulatory and/or respiratory insufficiency Inclusion Criteria for the LV unloading trial domain (VA ECMO + IABP vs VA ECMO alone): * Cardiogenic shock * Having received VA ECMO support for severe circulatory (and respiratory insufficiency). * Age ≥ 18 years * Initiation of LV unloading (IABP or Impella) possible ≤ 8 hours after ECMO initiation Exclusion criteria for the registry backbone * Objection to participation in the registry by the patient and/or proxy * VA ECMO usage confined to the period during surgery or another intervention (the VA ECMO was removed at the end of the intervention in the operation room). Exclusion criteria for the LV unloading trial domain (VA ECMO + IABP vs VA ECMO alone) * No (deferred) informed consent provided by the patient and/or proxy. * Pregnancy * ECMO usage confined to the period during surgery or another intervention (the ECMO was removed at the end of the intervention). * Isolated right ventricular failure (e.g. due to pulmonary embolism). * Left ventricular assist device (LVAD), Impella or IABP in situ. * Ventricular septal defect or papillary muscle rupture as the cause of shock. * Thoracic or abdominal aortic dissection. * Moderate or severe aortic regurgitation * Mechanical prosthesis in mitral valve position

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Conditions

The condition(s) this trial relates to.

cardiogenic shock Shock, Cardiogenic

As listed by the trial registrant

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

Cardiogenic shock

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    14 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AZ Sint-Jan Brugge

    RECRUITING

    Bruges, Belgium

  • Amphia hospital

    NOT_YET_RECRUITING

    Breda, North Brabant, 4818 CK, Netherlands

  • Amsterdam University Medical Center

    NOT_YET_RECRUITING

    Amsterdam, North Holland, 1105 AZ, Netherlands

  • Antonius hospital

    NOT_YET_RECRUITING

    Nieuwegein, Utrecht, 3435 CM, Netherlands

  • Catharina hospital

    NOT_YET_RECRUITING

    Eindhoven, North Brabant, 5623 EJ, Netherlands

  • Erasmus Medical Center

    RECRUITING

    Rotterdam, South Holland, 3015 GD, Netherlands

  • Haga ziekenhuis

    NOT_YET_RECRUITING

    The Hague, South Holland, 2545 AA, Netherlands

  • Leiden University Medical Center

    NOT_YET_RECRUITING

    Leiden, South Holland, 2333 ZA, Netherlands

  • Maastricht UMC

    RECRUITING

    Maastricht, Netherlands

  • OLVG

    RECRUITING

    Amsterdam, Netherlands

  • Radboud UMC

    RECRUITING

    Nijmegen, Netherlands

  • UZ Gent

    RECRUITING

    Ghent, Belgium

  • University Medical Center Utrecht

    NOT_YET_RECRUITING

    Utrecht, Utrecht, 3584 CX, Netherlands

  • ZOL Genk

    RECRUITING

    Genk, Belgium

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