An observational study in Coronary Artery Bypass, Off-Pump and Iron Deficiencies, sponsored by Yonsei University. Recruiting at 1 site in Korea, Republic of. Open to participants aged 29 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-05-06.
Sponsored by Yonsei University · Observational
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.
644 studies on the registry are indexed under Anemia, Iron-Deficiency; 105 are open to participants now.
This study's planned enrollment of 433 is above the median of 200 across 113 observational studies indexed under Anemia, Iron-Deficiency.
Browse Anemia, Iron-Deficiency studies →Yonsei University is the lead sponsor of 1,387 studies on the registry; 232 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Non-anemic patients who underwent off pump coronary artery bypass surgery
Exclusion Criteria:
Patient who did not meet the criteria for iron deficiency (see below)
patients with preoperative iron profile of either of the following were defined as iron deficient: 1. serum ferritin \<100mcg/L 2. 100mcg/L \< serum ferritin \<300mcg/L and * transferrin saturation \< 20% or * C reactive protein ≥ 5mg/L
Number of participants with in hospital mortality, stroke, deep sternal infection, hemostatic reoperation, delirium
This outcome is a composite of the following: 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. The occurrence of any one of these was regarded as primary end point met.
Time frame: from the end of surgery until patient discharge (assessed up to day 60)
Number of participants with acute kidney injury
This outcome is a composite of the following: 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. The occurrence of any one of these was regarded as primary end point met.
Time frame: until 7 days after surgery
Number of participants with post operative myocardial infarction
This outcome is a composite of the following: 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. The occurrence of any one of these was regarded as primary end point met.
Time frame: until 48 hours post-surgery
Post discharge hemoglobin
Data of hemoglobin levels after discharge until 1 year after surgery was collected to evaluate hemoglobin recovery to preoperative baseline levels.
Time frame: Until 1 year after surgery
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Yonsei University