Iron Deficiency in Pediatric Heart Surgery

Iron Deficiency Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06276608
• Other study ID #: PED_Fe_def
• Status: Recruiting
• Start date: February 23, 2024
• Est. completion date: June 30, 2024

Study information

• Verified date: February 2024
• Source: Queen Fabiola Children's University Hospital
• Contact: Denis Schmartz, MD
• Phone: +3225553919
• Email: denis.schmartz[@]hubruxelles.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 30, 2024
• Est. primary completion date: April 20, 2024
• Gender: All
• Age group: N/A to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Cardiac Surgical Procedures
• Congenital Heart Disease in Children
• Heart Defects, Congenital
• Heart Diseases
• Iron Deficiency Anemia

Intervention

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

Locations

Country	Name	City	State
Belgium	H.U.B - Hôpital Universitaire des Enfants Reine Fabiola	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Queen Fabiola Children's University Hospital

Country where clinical trial is conducted

Belgium, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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