Beijing Anzhen Hospital
Beijing, Beijing Municipality, 100029, China
Location status: Recruiting
Location contact
Liangshan Wang, MD
CONTACT
Xiaotong Hou Hou, MD, PhD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06872021
The goal of this multicenter, randomized trial is to compare early early left ventricular unloading by Intra-aortic Balloon Pump (IABP) versus conventional approach in patients with cardiogenic shock (CS) undergoing venoarterial extracorporeal membrane oxygenation (VA-ECMO). The main question it aims to answer is :
• If left ventricular unloading by IABP as compared with the conventional approach will improve the outcomes in patients undergoing VA-ECMO.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Beijing, Beijing Municipality, 100029, China
Location status: Recruiting
Liangshan Wang, MD
CONTACT
Xiaotong Hou Hou, MD, PhD
PRINCIPAL_INVESTIGATOR
The role of IABP combined with VA-ECMO in patients with CS remains unclear. Therefore, investigators will conduct a prospective randomized clinical trial to explore the effect of early IABP use for LV unloading after VA-ECMO on outcomes in patients with CS. Investigators will randomly assign 358 patients receiving peripheral VA-ECMO to the ECMO+IABP group (n=179) or the ECMO group (n=179). The primary end point was the 30-day mortality.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients receive IABP for left ventricular unloading within 6 hours after VA-ECMO initiation.
Patients do not receive mechanical unloading within 6 hours after VA-ECMO initiation.
Time frame: 30 days
Time frame: 30 days
Time frame: 30 days
Time frame: 30 days
Time frame: 30 days
Time frame: 30 days
Time frame: 30 days
Time frame: 30 days
Time frame: 30 days
Time frame: 30 days
Vasoactive inotropic score (VIS), in µg/kg/min, was calculated as follows: dopamine + dobutamine + 100 epinephrine + 100 norepinephrine + 15×milrinone. Higher VIS predict worse outome.
Time frame: 30 days
Time frame: 30 days
Time frame: 30 days
Time frame: 30 days
Time frame: 30 days
Time frame: 30 days
BARC type III or V
Time frame: 30 days
ECMO side/ IABP side
Time frame: 30 days
Time frame: 30 days
With or without culture result
Time frame: 30 days
Time frame: 30 days
Contact information is provided by the study sponsor or research team.
Beijing Anzhen Hospital
Other
Early Intra-aortic Balloon Pump Use After Venoarterial Extracorporeal Membrane Oxygenation: The EASE-ECMO Randomized Clinical Trial
Acronym: EASE-ECMO
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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