EA-230 on the Length of Hospital Stay Following On-Pump Coronary Artery Bypass Grafting Surgery
Research type
Research Study
Full title
An International, Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Trial on the Effects of EA-230 on the Length of Hospital Stay Following On-Pump Coronary Artery Bypass Grafting Surgery
IRAS ID
1013319
Contact name
Elke Wachem
Contact email
Sponsor organisation
EBI Anti Sepsis B.V.
Eudract number
2025-525023-39
Research summary
Coronary-Artery Bypass Grafting (CABG) is a common cardiac (heart) surgery associated with postoperative complications such as pain, heart and lung issues, infections, blood clots, irregular heart rhythms, and slower recovery, particularly for older patients or those with other health problems, leading to longer hospital stays. These problems stem from the body’s stress response to surgery, which damages blood vessels and organs. EA-230 is a drug which affects protein signalling in the body to protect blood vessels and support tissue repair, and previous trials have shown that it helps patients recover faster after surgery, therefore reducing hospital stays and need for post-surgery treatments and procedures, and lowering the duration of serious complications from surgery. These trials also demonstrated that EA-230 was well tolerated and safe among participants. This trial aims to confirm the efficacy of EA-230 administered intravenously, and evaluate how it impacts the length of hospital stay in patients receiving CABG surgery as compared with a placebo. 50 Male and female patients with coronary artery disease (CAD) receiving CABG with at least 3 bypasses, with or without valve replacement, will be recruited for this study from 1 hospital site in the UK. The duration of the trial for patients, from enrolment to the final visit, is approximately 1 month. There is a total of 10 visits, including a screening, a preoperative, and 2 remote visits. The screening period is (up to) 42 days, and the postoperative follow-up period is 28 days. During these visits, study doctors will monitor the participants, take blood samples and ask them about any symptoms they are having and medications they are taking. After the participants are discharged, the doctors will follow up with them via telephone call.
REC name
South West - Central Bristol Research Ethics Committee
REC reference
26/SW/0012
Date of REC Opinion
3 Mar 2026
REC opinion
Further Information Favourable Opinion