Impact of iron deficiency on outcomes after off-pump heart surgery
Effect of Non-anemic Iron Deficiency on Outcome Following Off-pump Coronary Revascularization
Yonsei University · NCT06399627
This study looks at how having enough iron before heart surgery affects recovery and complications in patients who aren't anemic.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 433 (estimated) |
| Ages | 29 Years to 85 Years |
| Sex | All |
| Sponsor | Yonsei University (other) |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06399627 on ClinicalTrials.gov |
What this trial studies
This observational study examines patients who underwent off-pump coronary artery bypass surgery at a single center from November 2016 to May 2023. It focuses on non-anemic patients, dividing them into two groups based on their preoperative iron status: iron replete and iron deficient. The study aims to compare the outcomes of these two cohorts, particularly looking at complications such as mortality, acute kidney injury, and other postoperative issues. The research also tracks hemoglobin recovery over a year following surgery.
Who should consider this trial
Good fit: Ideal candidates are non-anemic patients who have undergone off-pump coronary artery bypass surgery within the specified timeframe.
Not a fit: Patients with preoperative anemia or those undergoing emergency or complex cardiac surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify the importance of iron status in improving surgical outcomes for patients undergoing coronary artery bypass surgery.
How similar studies have performed: While the specific approach of this study is less common, previous research has indicated that iron status can significantly impact surgical outcomes, suggesting potential for meaningful insights.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Seoul
- Yonsei University Health system, Severance Hospital — Seoul, Korea, Republic of (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Coronary Artery Bypass, Off-Pump, Iron Deficiencies