NCT04986033

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
135

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 21, 2021

Completed
11 days until next milestone

Study Start

First participant enrolled

August 1, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 2, 2021

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2024

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2024

Completed
Last Updated

October 2, 2025

Status Verified

September 1, 2025

Enrollment Period

3 years

First QC Date

July 21, 2021

Last Update Submit

September 28, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Up to 1month

Eligibility Criteria

Age20 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who consented to study enrollment among patients scheduled for off-pump coronary artery bypass graft

You may qualify if:

  • \. Patients over 20 years of age undergoing off-pump coronary artery bypass graft

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Cardiac Anesthesiology, Department of Anesthesiology and Pain Medicine, Cardiovascular Hospital, Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea

Seoul, South Korea

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Seo Hee Ko

    Division of Cardiac Anesthesiology, Department of Anesthesiology and Pain Medicine, Cardiovascular Hospital, Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2021

First Posted

August 2, 2021

Study Start

August 1, 2021

Primary Completion

July 15, 2024

Study Completion

July 30, 2024

Last Updated

October 2, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations