Iron Deficiency in Pediatric Heart Surgery

NCT ID: NCT06276608

Last Updated: 2024-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-23

Study Completion Date

2024-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Pediatric cardiac surgery patients

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

Iron status

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Queen Fabiola Children's University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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H.U.B - Hôpital Universitaire des Enfants Reine Fabiola

Brussels, , Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Denis Schmartz, MD

Role: CONTACT

+3225553919

Ariane Willems, MD, PhD

Role: CONTACT

+322477331

Facility Contacts

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Denis Schmartz, MD

Role: primary

+3225553919

References

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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.

Reference Type BACKGROUND
PMID: 35722123 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33613898 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34145102 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15855050 (View on PubMed)

Other Identifiers

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PED_Fe_def

Identifier Type: -

Identifier Source: org_study_id

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