Iron Deficiency in Pediatric Heart Surgery

Iron Deficiency in Pediatric Heart Surgery: Impact on Anemia, Transfusion and Complications, a Retrospective Cohort Study

The prevalence of iron deficiency in pediatric cardiac surgery patients is not very well known. Iron deficiency can lead to anemia, higher transfusion rates and possibly higher complication rates. In this retrospective study, the iron status of all patients undergoing pediatric cardiac surgery at our institution between January 2019 and december 2023 will be analyzed. Together with iron status, transfusion requirements as well as complications will be recorded. Iron status will be reported with descriptive statistics, patients with or without iron deficiency will be compared using non-parametric tests.

Study Overview

• Status: Recruiting
• Conditions: Iron Deficiency Anemia; Congenital Heart Disease in Children; Cardiac Surgical Procedures; Iron Deficiencies
• Intervention / Treatment: Diagnostic test: Iron status

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Denis Schmartz, MD; Phone Number: +3225553919; Email: denis.schmartz@hubruxelles.be
• Study Contact Backup: Name: Ariane Willems, MD, PhD; Phone Number: +322477331; Email: ariane.willems@hubruxelles.be

Study Locations

• Belgium
  • Brussels, Belgium, 1020
    • Recruiting
    • H.U.B - Hôpital Universitaire des Enfants Reine Fabiola
    • Contact: Denis Schmartz, MD; Phone Number: +3225553919; Email: denis.schmartz@hubruxelles.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

All patients who underwent pediatric cardiac surgery at our institution between January 1, 2019 and December 31, 2023

Description

Inclusion Criteria:

• All patients who underwent pediatric cardiac surgery at our institution between January 1, 2019 and December 31, 2023

Exclusion Criteria:

• Incomplete medical charts
• Patients who did not consent to the use of their medical data

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pediatric cardiac surgery patients; All patients who underwent pediatric cardiac surgery in our institution between January 1, 2019 and december 31, 2023	Diagnostic test: Iron status; Iron status will be based on preoperative ferritin levels: a ferritin < 10 mcg/L will be considered as iron deficiency, ferritin levels > 10 mcg/L will be considered normal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of preoperative iron deficiency (%)	A preoperative ferritin < 10 mcg/L will be considered as iron deficiency. Iron deficiency will be reported using descriptive statistics (mean, standard deviation, median, interquartile range, %)	24 hours
Complications	The complication rate (%) will be reported. Complications are defined by the occurence of one or more of the following events: transfusion rate (%); volume of packed red cells transfused (mL/kg); perioperative blood loss (mL/kg); need for surgical re-exploration (%); intensive care stay (days); new renal insufficiency (%); use of inotropes (%); 28 day mortality (%) The frequency of any single item will also be reported (%)	28 days

Collaborators and Investigators

• Sponsor: Queen Fabiola Children's University Hospital

Publications and helpful links

General Publications

• Christen S, Finckh B, Lykkesfeldt J, Gessler P, Frese-Schaper M, Nielsen P, Schmid ER, Schmitt B. Oxidative stress precedes peak systemic inflammatory response in pediatric patients undergoing cardiopulmonary bypass operation. Free Radic Biol Med. 2005 May 15;38(10):1323-32. doi: 10.1016/j.freeradbiomed.2005.01.016.
• Gao P, Wang X, Zhang P, Jin Y, Bai L, Wang W, Li Y, Liu J. Preoperative Iron Deficiency Is Associated With Increased Blood Transfusion in Infants Undergoing Cardiac Surgery. Front Cardiovasc Med. 2022 Jun 2;9:887535. doi: 10.3389/fcvm.2022.887535. eCollection 2022.
• Sidhu S, Kakkar S, Dewan P, Bansal N, Sobti PC. Adherence to Iron Chelation Therapy and Its Determinants. Int J Hematol Oncol Stem Cell Res. 2021 Jan 1;15(1):27-34. doi: 10.18502/ijhoscr.v15i1.5247.
• Temel HH, Kumbasar U, Buber E, Aksoy Y, Cavdar S, Dogan R, Demircin M, Pasaoglu I. Comparison of antioxidant reserve capacity of children with acyanotic & cyanotic congenital heart disease. Indian J Med Res. 2020 Dec;152(6):626-632. doi: 10.4103/ijmr.IJMR_2215_18.

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2024
• Primary Completion (Estimated): April 20, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: February 13, 2024
• First Submitted That Met QC Criteria: February 22, 2024
• First Posted (Actual): February 26, 2024

Study Record Updates

• Last Update Posted (Estimated): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Metabolic Diseases; Congenital Abnormalities; Hematologic Diseases; Anemia, Hypochromic; Iron Metabolism Disorders; Cardiovascular Abnormalities; Heart Diseases; Anemia, Iron-Deficiency; Anemia; Heart Defects, Congenital; Iron Deficiencies
• Other Study ID Numbers: PED_Fe_def

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No