RECRUITINGINTERVENTIONAL
A Study on the Effects of Left Ventricular Unloading in the Setting of VA ECMO Support
Randomized Embedded Multifactorial Adaptive Platform in ExtraCorporeal Membrane Oxygenation (REMAP ECMO) - Left Ventricular Unloading Study
About This Trial
REMAP ECMO is a registry based platform in which multiple response adaptive randomized clinical trials (trial domains) will be embedded. These trial domains will, in a perpetual way, study the effects of a range of patient management strategies which aim to improve VA ECMO weaning success. A first trial domain will address the effects of left ventricular (LV) unloading through intra-aortic balloon pumping on weaning succes in VA ECMO supported patients.
Who May Be Eligible (Plain English)
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) willing to sign a consent form 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
DEVICE
Intra-aortic balloon pump
An IABP is placed percutaneously into the thoracic aorta and supports the heart through synchronized inflation and deflation of a balloon.
Locations (14)
AZ Sint-Jan Brugge
Bruges, Belgium
ZOL Genk
Genk, Belgium
UZ Gent
Ghent, Belgium
Amphia hospital
Breda, North Brabant, Netherlands
Catharina hospital
Eindhoven, North Brabant, Netherlands
Amsterdam University Medical Center
Amsterdam, North Holland, Netherlands
Leiden University Medical Center
Leiden, South Holland, Netherlands
Erasmus Medical Center
Rotterdam, South Holland, Netherlands
Haga ziekenhuis
The Hague, South Holland, Netherlands
Antonius hospital
Nieuwegein, Utrecht, Netherlands
University Medical Center Utrecht
Utrecht, Utrecht, Netherlands
OLVG
Amsterdam, Netherlands
Maastricht UMC
Maastricht, Netherlands
Radboud UMC
Nijmegen, Netherlands