Randomized Embedded Multifactorial Adaptive Platform in ExtraCorporeal Membrane Oxygenation (REMAP ECMO) - Left Ventricular Unloading Study

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Having received ECMO support for severe circulatory and/or respiratory insufficiency

• 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

Locations
Other Locations
Netherlands
Amsterdam University Medical Center
NOT_YET_RECRUITING
Amsterdam
Amphia hospital
NOT_YET_RECRUITING
Breda
Catharina hospital
NOT_YET_RECRUITING
Eindhoven
Leiden University Medical Center
NOT_YET_RECRUITING
Leiden
Antonius hospital
NOT_YET_RECRUITING
Nieuwegein
Erasmus Medical Center
RECRUITING
Rotterdam
Haga ziekenhuis
NOT_YET_RECRUITING
The Hague
University Medical Center Utrecht
NOT_YET_RECRUITING
Utrecht
Contact Information
Primary
Myrthe van Steenwijk
m.p.j.vansteenwijk@erasmusmc.nl
+31627535136
Backup
Christiaan Meuwese
c.meuwese@erasmusmc.nl
+31631135752
Time Frame
Start Date: 2023-06-08
Estimated Completion Date: 2028-06-01
Participants
Target number of participants: 430
Treatments
Experimental: IABP unloading arm
This group of patients will receive an intra-aortic balloon pump (IABP) as an adjunct to VA ECMO support. When allocated to the IABP unloading arm, patients must receive an IABP within 8 hours after VA ECMO initiation.
No_intervention: ECMO alone arm
This group of patients will receive VA ECMO support without left ventricular unloading device after randomization.
Related Therapeutic Areas
Sponsors
Collaborators: Dutch Heart Foundation
Leads: Erasmus Medical Center

This content was sourced from clinicaltrials.gov