Effect of Non-anemic Iron Deficiency on Outcome Following Off-pump Coronary Revascularization (NCT06399627) | Clinical Trial Compass
UnknownNot Applicable
Effect of Non-anemic Iron Deficiency on Outcome Following Off-pump Coronary Revascularization
South Korea433 participantsStarted 2016-11-01
Plain-language summary
This is a single center retrospective study of patients who underwent off pump coronary artery bypass surgery between 2016.11\~2023.05. From this patient group, preoperatively non-anemic patients were selected and were divided into 2 cohorts according to their preoperative iron status; iron replete and iron deficient. These two cohorts were compared to evaluate the effect of preoperative iron deficiency on patient outcomes.
The primary end point was the occurrence of composite morbidity/mortality end points which were: in hospital mortality, acute kidney injury (AKI), stroke, deep sternal infection, hemostatic reoperation, prolonged mechanical ventilation of more than 24hours, delirium and postoperative myocardial infarction. Occurrence of any one of these outcomes counted as primary end point met. Secondary outcome was to evaluate and compare hemoglobin recovery of iron replete and deficient patients until one year after surgery.
Who can participate
Age range
29 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients who received off pump coronary artery bypass surgery (OPCAB) between 2016.11.01-2023.05.31
Exclusion Criteria:
* preoperative anemia (male Hb \<13g/dL, female Hb\<12g/dL)
* emergency surgery
* redo-off pump coronary artery bypass surgery
* minimally invasive coronary artery bypass surgery
* OPCAB in conjunction with other cardiac surgical procedures (e.g. valve surgery, graft replacement surgery of the aorta)
* intraoperative on pump conversion
* lack of sufficient preoperative data (ferritin, transferrin saturation, C-reactive protein) to determine iron status
* administration of intravenous iron within 4 weeks or parenteral iron of more than 2 weeks prior to surgery
* enrollemnt in other clinical studies
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants with in hospital mortality, stroke, deep sternal infection, hemostatic reoperation, delirium
Timeframe: from the end of surgery until patient discharge (assessed up to day 60)
2
Number of participants with acute kidney injury
Timeframe: until 7 days after surgery
3
Number of participants with post operative myocardial infarction