ECMOEASE-ECMONCT06872021
Early Intra-aortic Balloon Pump Use After Venoarterial Extracorporeal Membrane Oxygenation
A study testing Early IABP use and Conventional approach in people with ECMO, run by Beijing Anzhen Hospital at 1 site in China.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ECMO
- What is being tested?
- Early IABP use and Conventional approach
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 358 participants
- Where
- 1 siteChina
- Study dates
- 22 Mar 2026to 1 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age of ≥18
- Cardiogenic shock(defined as a systolic blood pressure of less than 90 mm Hg for more than 30 minutes or the initiation of catecholamines to maintain a systolic pressure of more than 90 mm Hg, an arterial lactate level of more than 3 mmol per liter, and signs of impaired organ perfusion)
- Successful implantation of VA-ECMO
- Informed consent
Who cannot join
- SCAI shock stage A or B
- Presence of moderate to severe aortic insufficiency or aortic dissection
- Severe peripheral vascular disease
- Post-cardiotomy cardiogenic shock(non-CABG procedure) or bridging to cardiac procedure(heart transplantation or LVAD).
- VA-ECMO for definite non-cardiac causes
- Isolated right ventricular failure
Show all 14Show fewer
- V-A ECMO usage confined to the period during surgery or other interventions
- Ischemic mechanical complications(eg Ventricular septal defect, papillary muscle rupture)
- Extracorporeal cardiopulmonary resuscitation
- LVAD, Impella or IABP in situ.
- Severe bleeding
- Terminal malignancy
- Irreversible neurologic injury
- Pregnancy or lactation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Anzhen Hospital
Beijing, Beijing Municipality, 100029
Liangshan Wang, MD, 86-13811363372, wangliangshanbam@sina.com
Xiaotong Hou Hou, MD, PhD
About this study
Official title: Early Intra-aortic Balloon Pump Use After Venoarterial Extracorporeal Membrane Oxygenation: The EASE-ECMO Randomized Clinical Trial
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.
Read the detailed description
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.
- Conditions
- ECMO
- Being tested
- Early IABP use, Conventional approach
- Keywords
- ECMO, IABP, LV unloading
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early IABP useOther
Patients receive IABP for left ventricular unloading within 6 hours after VA-ECMO initiation.
Conventional approachOther
Patients do not receive mechanical unloading within 6 hours after VA-ECMO initiation.
| Study group | Role | What they receive |
|---|---|---|
| ECMO+IABP group | Experimental | Patients receive IABP for left ventricular unloading within 6 hours after VA-ECMO initiation. Receives: Other: Early IABP use |
| ECMO group | Active comparator | Patients do not receive mechanical unloading within 6 hours after VA-ECMO initiation. Receives: Other: Conventional approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day mortality
Measured: 30 days
Secondary outcomes (20)
weaning from VA-ECMO
Measured: 30 days
Rate of advanced mechanical unloading
Measured: 30 days
Left Ventricular Function of survivors
Measured: 30 days
In-hospital Mortality
Measured: 30 days
Day of Mechanical Circulatory Support Device Weaning
Measured: 30 days
Rate of pulmonary congestion on chest X-ray
Measured: 30 days
Duration of VA-ECMO
Measured: 30 days
Lactate clearance rate at 12 and 24 hours
Measured: 30 days
Relative decrease in vasoactive inotropic score(VIS) at 12 and 24 hours
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.
Measured: 30 days
Reduction in Myocardial Injury Biomarkers (cTnI/cTnT)
Measured: 30 days
Reduction in N-terminal pro-B-type Natriuretic Peptide (NT-proBNP)
Measured: 30 days
Rate of CRRT
Measured: 30 days
Rate of ventricular arrhythmia
Measured: 30 days
Rate of stroke
Measured: 30 days
Rate of bleeding
BARC type III or V
Measured: 30 days
Rate of limb ischemia
ECMO side/ IABP side
Measured: 30 days
Duration of mechanical ventilation
Measured: 30 days
Rate of infection
With or without culture result
Measured: 30 days
ICU length of stay
Measured: 30 days
Hospital length of stay
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2025
- Study start22 Mar 2026
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ECMOStudies of the same condition, open and under way.
- More trials run by Beijing Anzhen HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 358 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaotong Hou, Beijing Anzhen Hospital
- Investigators
- Xiaotong Hou, MD, PhD, Principal investigator, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06872021
- Sponsor's protocol ID
- KS2025197
- Acronym
- EASE-ECMO
- Status last verified
- Mar 2026
- First submitted
- 3 Mar 2025
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Intra-aortic Balloon Pump Use After Venoarterial Extracorporeal Membrane Oxygenation: The EASE-ECMO Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06872021
- Acronym / sponsor ID
- EASE-ECMO / KS2025197
- Conditions
- ECMO
- Keywords
- ECMO, IABP, LV unloading
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 358 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Study start
- 22 Mar 2026 (actual)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 12 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ECMO+IABP group | Experimental | Other: Early IABP usePatients receive IABP for left ventricular unloading within 6 hours after VA-ECMO initiation. |
| ECMO group | Active comparator | Other: Conventional approachPatients do not receive mechanical unloading within 6 hours after VA-ECMO initiation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age of ≥18
- Cardiogenic shock(defined as a systolic blood pressure of less than 90 mm Hg for more than 30 minutes or the initiation of catecholamines to maintain a systolic pressure of more than 90 mm Hg, an arterial lactate level of more than 3 mmol per liter, and signs of impaired organ perfusion)
- Successful implantation of VA-ECMO
- Informed consent
Key exclusion criteria (14 listed)
- SCAI shock stage A or B
- Presence of moderate to severe aortic insufficiency or aortic dissection
- Severe peripheral vascular disease
- Post-cardiotomy cardiogenic shock(non-CABG procedure) or bridging to cardiac procedure(heart transplantation or LVAD).
- VA-ECMO for definite non-cardiac causes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early IABP usePatients receive IABP for left ventricular unloading within 6 hours after VA-ECMO initiation. | Other | ECMO+IABP group |
| Conventional approachPatients do not receive mechanical unloading within 6 hours after VA-ECMO initiation. | Other | ECMO group |
Primary outcome
30-day mortality
Time frame: 30 days
20 secondary outcomes
weaning from VA-ECMO
Time frame: 30 days
Rate of advanced mechanical unloading
Time frame: 30 days
Left Ventricular Function of survivors
Time frame: 30 days
In-hospital Mortality
Time frame: 30 days
Day of Mechanical Circulatory Support Device Weaning
Time frame: 30 days
Rate of pulmonary congestion on chest X-ray
Time frame: 30 days
Duration of VA-ECMO
Time frame: 30 days
Lactate clearance rate at 12 and 24 hours
Time frame: 30 days
Relative decrease in vasoactive inotropic score(VIS) at 12 and 24 hours
Time frame: 30 days
Reduction in Myocardial Injury Biomarkers (cTnI/cTnT)
Time frame: 30 days
Reduction in N-terminal pro-B-type Natriuretic Peptide (NT-proBNP)
Time frame: 30 days
Rate of CRRT
Time frame: 30 days
Rate of ventricular arrhythmia
Time frame: 30 days
Rate of stroke
Time frame: 30 days
Rate of bleeding
Time frame: 30 days
Rate of limb ischemia
Time frame: 30 days
Duration of mechanical ventilation
Time frame: 30 days
Rate of infection
Time frame: 30 days
ICU length of stay
Time frame: 30 days
Hospital length of stay
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiaotong Hou, MD, PhD principal investigator
Beijing Anzhen Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early IABP use and Conventional approach in people with ECMO, run by Beijing Anzhen Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaotong Hou, MD, PhD (010-64456631, xt.hou@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-day mortality (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.