EA-230 is a new therapy that may help people recover faster and have fewer problems after bypass surgery. In an earlier clinical trial, participants who received EA-230 during Coronary Artery Bypass surgery stayed in the Intensive Care Unit (ICU) and the hospital for a shorter time and had fewer serious complications, compared to those who received a placebo (an inactive therapy). The use of EA-230 was safe and well tolerated. This trial will test EA-230 in more participants to see if it really works and is safe to use in the future.
This is a Phase III trial. It will take place in multiple locations and will follow a double-blind, randomized, placebo-controlled clinical design, meaning neither doctors nor participants will know whether they receive EA-230 or placebo during the trial. Assignment to EA-230 or placebo occurs by chance, like throwing dice. The total duration of the trial, including medical check-ups, will be approximately 71 days. There is a total of 10 visits, including a screening-, a pre-operative-, and 2 remote visits. 7 of these visits are during your stay at the hospital.
Patients aged ≥18 years, both male and female.
Patients scheduled for elective on-pump CABG with at least 3 bypasses, with or without valve replacement.
Willing and able to give written informed consent.
Patients undergoing non-elective on-pump CABG (i.e., emergency surgery). Emergency surgery is defined as planned surgery within 24 hours of diagnosis.
Cardiogenic shock or hemodynamic instability that requires inotropes, vasopressors, or other mechanical devices, such as an intra-aortic balloon counter-pulsation (IABP), within 24 hours prior to surgery.
Use of a left ventricular assist device (LVAD), or intra-aortic balloon pump or other cardiac devices, within 7 days prior to surgery.
A requirement for any of the following within 7 days prior to surgery: defibrillator or permanent pacemaker, mechanical ventilation, IABP, LVAD, or other forms of mechanical circulatory support.
Parallel
EA-230 90mg/kg/hour
DrugIntravenous administration of 90mg/kg per hour for 4 hours.
Placebo
DrugPlacebo administered intravenously for 4 hours
Required postoperative hospital length of stay
Median postoperative duration, from the moment of first incision until the time when a patient is eligible to be discharged from the hospital.
the effect of EA-230 on the duration of moderate and severe POCs
Median cumulative duration of moderate and severe Single Organ Outcome Measures (SOOMs) according to the European Perioperative Clinical Outcome (EPCO) definitions during the trial.
Hemodynamic stability via Net fluid balance
Median cumulative Net fluid balance (NFB) at the start of IMP administration (T0) and up to 24 and 48 hours thereafter.
Hemodynamic stability via VIS score
Cumulative dose of vasopressors and inotropes used and vasopressor-inotropic scores at the start of IMP administration (T0) and up to 24 and 48 hours thereafter, compared between treatment arms. Up to 2 days (48 hours) after start of surgery (first incision)
Required postoperative ICU length of stay
Median postoperative duration, from the moment of first incision until the time when a patient is eligible to be discharged from the ICU and transferred to the general ward.
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EBI Anti Sepsis BV
Lead sponsor
CR2O B.V.
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
