Coronary Artery DiseaseNCT04986033
Association Between Vitamin D and Perioperative Hemoglobin Levels in Patients Undergoing Off-pump Coronary Artery Bypass Graft Surgery: Role of Hepcidin
An observational study of Coronary Artery Disease, run by Yonsei University at 1 site in South Korea.
Trial summary
Preoperative anemia is present in more than 50% of patients undergoing cardiac surgery, which is associated with increased risk of transfusion, increased length of stay in the intensive care unit, and increased incidence of renal failure and mortality. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 135 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Aug 2021to 30 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Adult, Older adult
Study population: Patients who consented to study enrollment among patients scheduled for off-pump coronary artery bypass graft
Who may be able to join
- 1. Patients over 20 years of age undergoing off-pump coronary artery bypass graft
Who cannot join
- Emergency operation
- Minimal invasive coronary artery bypass graft
- Cooperative operation with other surgery
- Patients who need a mechanical ventricular assist device
- Patients with chronic kidney disease (eGFR < 30)
- Patients who have a end stage renal disease and need a hemodialysis
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- Patients with a low hemoglobin (Hb < 10) before surgery
- Patients who have a some disease(leukemia, myeloma, aplastic anemia, sickle cell anemia, etc) affecting hematopoiesis
- Patients with a liver cirrhosis
- Patients who receive vit. D, iron supplements, erythropoietin within 6 months
- Patients who cannot understand the informed consent (eg. Foreigner, patients with cognitive dysfunction, etc)
- Patients who disagree this study
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Division of Cardiac Anesthesiology, Department of Anesthesiology and Pain Medicine, Cardiovascular Hospital, Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea
Seoul
About this study
Preoperative anemia is present in more than 50% of patients undergoing cardiac surgery, which is associated with increased risk of transfusion, increased length of stay in the intensive care unit, and increased incidence of renal failure and mortality.
To date, clinical research on perioperative anemia has been focused on finding and treating other underlying causes of anemia, lowering the threshold for transfusion, and performing careful transfusion.
Read more
However, recently, it was known that hepcidin and erythroferrone are related to iron metabolism and absorption, vitamin D has an inverse correlation with the development of anemia, and is related to hepcidin concentration control.
Therefore, in this study, the relationship between vitamin D, hepcidin concentration and perioperative hemoglobin level in patients with off-pump coronary artery bypass graft surgery was investigated together.
- Conditions
- Coronary Artery Disease
- Medical subject headings
- Coronary Artery Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Relationship about pre-operative vitamin D level and recovery of hemoglobin
Vitamin D is a fat-soluble vitamin, a regulator acting on bone and calcium metabolism, and is known to affect the pathophysiology of several chronic diseases, and is particularly closely related to heart disease.
Vitamin D deficiency was observed in 56% of patients undergoing cardiac surgery, and low vitamin D concentrations increased the risk of postoperative infection and organ failure, atrial fibrillation, and delirium.
It is also known that vitamin D is closely related to anemia by regulating the secretion of erythroferrone and changing the concentration of hepcidin.
Measured: Up to 1month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2021
- Study start1 Aug 2021
- Primary completion15 Jul 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Seo Hee Ko, Principal investigator, Division of Cardiac Anesthesiology, Department of Anesthesiology and Pain Medicine, Cardiovascular Hospital, Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04986033
- Sponsor's protocol ID
- 4-2021-0707
- Status last verified
- Sep 2025
- First submitted
- 21 Jul 2021
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Vitamin D and Perioperative Hemoglobin Levels in Patients Undergoing Off-pump Coronary Artery Bypass Graft Surgery: Role of Hepcidin
- ClinicalTrials.gov ID
- NCT04986033
- Acronym / sponsor ID
- 4-2021-0707
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 15 Jul 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 2 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Preoperative anemia is present in more than 50% of patients undergoing cardiac surgery, which is associated with increased risk of transfusion, increased length of stay in the intensive care unit, and increased incidence of renal failure and mortality.
To date, clinical research on perioperative anemia has been focused on finding and treating other underlying causes of anemia, lowering the threshold for transfusion, and performing careful transfusion.
However, recently, it was known that hepcidin and erythroferrone are related to iron metabolism and absorption, vitamin D has an inverse correlation with the development of anemia, and is related to hepcidin concentration control.
Therefore, in this study, the relationship between vitamin D, hepcidin concentration and perioperative hemoglobin level in patients with off-pump coronary artery bypass graft surgery was investigated together.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients who consented to study enrollment among patients scheduled for off-pump coronary artery bypass graft
Key inclusion criteria (1 listed)
- 1. Patients over 20 years of age undergoing off-pump coronary artery bypass graft
Key exclusion criteria (12 listed)
- Emergency operation
- Minimal invasive coronary artery bypass graft
- Cooperative operation with other surgery
- Patients who need a mechanical ventricular assist device
- Patients with chronic kidney disease (eGFR < 30)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Relationship about pre-operative vitamin D level and recovery of hemoglobin
Time frame: Up to 1month
Vitamin D is a fat-soluble vitamin, a regulator acting on bone and calcium metabolism, and is known to affect the pathophysiology of several chronic diseases, and is particularly closely related to heart disease. Vitamin D deficiency was observed in 56% of patients undergoing cardiac surgery, and low vitamin D concentrations increased the risk of postoperative infection and organ failure, atrial fibrillation, and delirium. It is also known that vitamin D is closely related to anemia by regulating the secretion of erythroferrone and changing the concentration of hepcidin.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seo Hee Ko principal investigator
Division of Cardiac Anesthesiology, Department of Anesthesiology and Pain Medicine, Cardiovascular Hospital, Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relationship about pre-operative vitamin D level and recovery of hemoglobin (time frame: Up to 1month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.