Actively Recruiting
Early Intra-aortic Balloon Pump Use After Venoarterial Extracorporeal Membrane Oxygenation: The EASE-ECMO Randomized Clinical Trial
Led by Beijing Anzhen Hospital · Updated on 2026-03-24
358
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effect of early use of an Intra-aortic Balloon Pump (IABP) for left ventricular unloading in patients with cardiogenic shock who are receiving venoarterial extracorporeal membrane oxygenation (VA-ECMO). This multicenter, randomized trial aims to determine whether early IABP use improves outcomes compared to the conventional approach without mechanical unloading. The study will include 358 patients to assess the impact on 30-day mortality and other clinical outcomes. Participants will be randomly assigned to one of two groups: the ECMO+IABP group, receiving IABP within 6 hours after VA-ECMO starts, or the ECMO group, which will not receive mechanical unloading within 6 hours. The main focus is on early intervention to unload the left ventricle in patients undergoing VA-ECMO treatment for cardiogenic shock. During the study, researchers will monitor participants for 30 days, measuring mortality, ability to wean from VA-ECMO, left ventricular function, rates of complications such as stroke, bleeding, infections, and length of hospital and intensive care stays. Various laboratory markers and imaging outcomes will also be evaluated to assess heart function and recovery. The trial intends to provide detailed information on the benefits and risks of early IABP use in this patient population.
CONDITIONS
Brief Title
Early Intra-aortic Balloon Pump Use After Venoarterial Extracorporeal Membrane Oxygenation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age of 18 years or older
- Diagnosis of cardiogenic shock defined by low blood pressure, high arterial lactate, and signs of poor organ perfusion
- Successful implantation of venoarterial extracorporeal membrane oxygenation (VA-ECMO)
- Provided informed consent to participate
You will not qualify if you...
- SCAI shock stage A or B
- Moderate to severe aortic valve leakage or aortic dissection
- Severe peripheral vascular disease
- Cardiogenic shock after heart surgery (non-CABG) or bridging to heart transplant or LVAD
- VA-ECMO used for non-cardiac causes
- Isolated right ventricular failure
- VA-ECMO use limited to during surgery or interventions
- Ischemic mechanical complications like ventricular septal defect or papillary muscle rupture
- Extracorporeal cardiopulmonary resuscitation
- Existing LVAD, Impella, or IABP device in place
- Severe bleeding
- Terminal cancer
- Irreversible neurologic injury
- Pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 30 days
Participants receive venoarterial extracorporeal membrane oxygenation (VA-ECMO). Early intra-aortic balloon pump (IABP) use for left ventricular unloading is initiated within 6 hours after VA-ECMO start for those in the experimental group. Those in the comparator group do not receive mechanical unloading within 6 hours.
Ongoing care during hospitalization with assessments as part of treatment
Duration - Up to 30 days after treatment start
Participants are monitored for outcomes including mortality, weaning from VA-ECMO, cardiac function, complications, and length of hospital stay through 30 days after treatment initiation.
Assessments during hospitalization and follow-up visits as needed
Trial Site Locations
Total: 1 location
1
Beijing Anzhen Hospital
Beijing, Beijing Municipality, China, 100029
Actively Recruiting
Research Team
X
Xiaotong Hou, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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