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IABP with VA ECMO for Cardiogenic Shock

Phase 2
Recruiting
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up hospital discharge up to 6 months
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to compare the use of a heart assist device called veno-arterial extracorporeal membrane oxygenation (VA ECMO) with or without an additional device to help the heart

Who is the study for?
This trial is for patients with non-postoperative cardiogenic shock, a severe heart condition where the heart can't pump enough blood. Participants must be receiving veno-arterial extracorporeal membrane oxygenation (VA ECMO) treatment.
What is being tested?
The study compares two approaches: one group receives VA ECMO alone, while the other gets VA ECMO plus left ventricular unloading using an intra-aortic balloon pump (IABP). The effects on heart and lung function will be measured through lab tests, echocardiography, and pulmonary artery catheter data.
What are the potential side effects?
Potential side effects include complications related to IABP like bleeding or vascular issues, infection risk from additional invasive procedures, and possible impact on organ function due to changes in circulatory support.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~hospital discharge up to 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and hospital discharge up to 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in pulmonary capillary wedge pressure
Secondary study objectives
Cardiac BIN1
Change in N-terminal pro b-type natriuretic peptide
Change in left ventricular end diastolic diameter
+11 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: With LV UnloadingExperimental Treatment1 Intervention
Patients on VA ECMO who randomize to receive LV unloading
Group II: Without LV UnloadingActive Control1 Intervention
Patients on VA ECMO who randomize to receive no LV unloading
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
IABP
2009
N/A
~160

Find a Location

Who is running the clinical trial?

University of MinnesotaOTHER
1,439 Previous Clinical Trials
1,621,854 Total Patients Enrolled
University of UtahLead Sponsor
1,147 Previous Clinical Trials
1,699,517 Total Patients Enrolled
~69 spots leftby Feb 2028
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