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

May 2, 2024 updated by: Yonsei University

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

433

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Korea, Republic of
- - Seoul, Korea, Republic of, 03722
    - Recruiting
    - Yonsei University Health System, Severance Hospital
    - Contact:
      
      seohee Ko
      
      Phone Number: 82-10-9345-6520
      
      Email: shk0207@yuhs.ac

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Sampling Method

Probability Sample

Study Population

Non-anemic patients who underwent off pump coronary artery bypass surgery

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
Iron replete Patient who did not meet the criteria for iron deficiency (see below)
Iron deficient patients with preoperative iron profile of either of the following were defined as iron deficient: serum ferritin <100mcg/L 100mcg/L < serum ferritin <300mcg/L and transferrin saturation < 20% or C reactive protein ≥ 5mg/L

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with in hospital mortality, stroke, deep sternal infection, hemostatic reoperation, delirium Time Frame: from 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.	from the end of surgery until patient discharge (assessed up to day 60)
Number of participants with acute kidney injury Time Frame: until 7 days after surgery	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.	until 7 days after surgery
Number of participants with post operative myocardial infarction Time Frame: until 48 hours post-surgery	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.	until 48 hours post-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post discharge hemoglobin Time Frame: Until 1 year after surgery	Data of hemoglobin levels after discharge until 1 year after surgery was collected to evaluate hemoglobin recovery to preoperative baseline levels.	Until 1 year after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2016

Primary Completion (Estimated)

May 31, 2024

Study Completion (Estimated)

May 31, 2024

Study Registration Dates

First Submitted

April 29, 2024

First Submitted That Met QC Criteria

May 2, 2024

First Posted (Actual)

May 6, 2024

Study Record Updates

Last Update Posted (Actual)