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Effect of Non-anemic Iron Deficiency on Outcome Following Off-pump Coronary Revascularization

Effect of Non-anemic Iron Deficiency on Outcome Following Off-pump Coronary Revascularization

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06399627
Enrollment
433
Registered
2024-05-06
Start date
2016-11-01
Completion date
2024-05-31
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Bypass, Off-Pump, Iron Deficiencies

Brief 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.

Interventions

None listed

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
29 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of participants with in hospital mortality, stroke, deep sternal infection, hemostatic reoperation, deliriumfrom the end of surgery until patient discharge (assessed up to day 60)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.
Number of participants with acute kidney injuryuntil 7 days after surgeryThis 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.
Number of participants with post operative myocardial infarctionuntil 48 hours post-surgeryThis 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.

Secondary

MeasureTime frameDescription
Post discharge hemoglobinUntil 1 year after surgeryData of hemoglobin levels after discharge until 1 year after surgery was collected to evaluate hemoglobin recovery to preoperative baseline levels.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026