ClinicalTrials.gg
RecruitingNCT06276608Updated Feb 28, 2024

Iron Deficiency in Pediatric Heart Surgery

An observational study in Iron Deficiencies, Iron Deficiency Anemia and Cardiac Surgical Procedures, sponsored by Queen Fabiola Children's University Hospital. Recruiting at 1 site in Belgium. Open to participants aged Up to 16 Years. Per ClinicalTrials.gov, last updated 2024-02-28.

Primary conditionAnemia, Iron-DeficiencyRegistry: Iron DeficienciesReclassifiedWhy we changed it
Registry
Iron Deficiencies — the first condition term the registry derived for this study.
ClinicalTrials.gg
Anemia, Iron-Deficiency
Why
  1. The study's listed conditions name Anemia, Iron-Deficiency, a narrower term within Iron Deficiencies.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Queen Fabiola Children's University Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Apr 2024, 2 years 6 months ago, but the record still lists the study as recruiting.
  • Started Feb 2024; still recruiting 2 years 8 months later.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
300
Ages
Up to 16 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Iron Deficiencies
  • Iron Deficiency Anemia
  • Cardiac Surgical Procedures
  • Congenital Heart Disease in Children

Browse trials for

03

In context

Anemia, Iron-Deficiency Reclassified

600 studies on the registry are indexed under Anemia, Iron-Deficiency; 95 are open to participants now.

This study's planned enrollment of 300 is above the median of 200 across 118 observational studies indexed under Anemia, Iron-Deficiency.

Browse Anemia, Iron-Deficiency studies →

Lead sponsor

Queen Fabiola Children's University Hospital is the lead sponsor of 28 studies on the registry; 6 are open to participants now.

Compared within Anemia, Iron-Deficiency, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Iron Deficiencies. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
Up to 16 Years
Sexes eligible
All
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Incomplete medical charts
  • Patients who did not consent to the use of their medical data
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
300 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • Diagnostic testIron 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

06

What researchers measure

Primary outcomes

  1. 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, %)

    Time frame: 24 hours

  2. 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 (%)

    Time frame: 28 days

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • 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. PubMed 35722123 ↗
  • 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. PubMed 33613898 ↗
  • 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. PubMed 34145102 ↗
  • 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. PubMed 15855050 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 28, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06276608
Lead sponsor
Queen Fabiola Children's University Hospital
Responsible party
Sponsor
First posted
Feb 26, 2024
Start date
Feb 23, 2024
Primary completion
Apr 20, 2024 (estimated)
Completion
Jun 30, 2024 (estimated)
Last update
Feb 28, 2024

Study contacts

Denis Schmartz, MD
Contact
denis.schmartz@hubruxelles.be
+3225553919
Ariane Willems, MD, PhD
Contact
ariane.willems@hubruxelles.be
+322477331

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion