Iron DeficienciesNCT06276608
Iron Deficiency in Pediatric Heart Surgery
An observational study of Iron Deficiencies and Iron Deficiency Anemia, run by Queen Fabiola Children's University Hospital at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages Up to 16 years
- Conditions the study is for
- Iron Deficiencies, Iron Deficiency Anemia, Cardiac Surgical Procedures
- What is being tested?
- Iron status
- How many people
- 300 participants
- Where
- 1 siteBelgium
- Study dates
- 23 Feb 2024to 30 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 16 years
- All sexes
- Child
Study population: All patients who underwent pediatric cardiac surgery at our institution between January 1, 2019 and December 31, 2023
Who may be able to join
- All patients who underwent pediatric cardiac surgery at our institution between January 1, 2019 and December 31, 2023
Who cannot join
- Incomplete medical charts
- Patients who did not consent to the use of their medical data
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
H.U.B - Hôpital Universitaire des Enfants Reine Fabiola
Brussels, 1020
Denis Schmartz, MD, +3225553919, denis.schmartz@hubruxelles.be
About this study
Official title: 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.
- Conditions
- Iron Deficiencies, Iron Deficiency Anemia, Cardiac Surgical Procedures, Congenital Heart Disease in Children
- Being tested
- Iron status
- Medical subject headings
- Iron Deficiencies, Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron statusDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| Pediatric cardiac surgery patients | All patients who underwent pediatric cardiac surgery in our institution between January 1, 2019 and december 31, 2023 Receives: Diagnostic Test: Iron status |
What is being measured
The primary outcome is the main question the study is designed to answer.
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, %)
Measured: 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 (%)
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start23 Feb 2024
- Primary completion20 Apr 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Iron DeficienciesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen Fabiola Children's University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06276608
- Sponsor's protocol ID
- PED_Fe_def
- Status last verified
- Feb 2024
- First submitted
- 13 Feb 2024
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 35722123Sidhu 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 33613898Temel 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 34145102Christen 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
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iron Deficiency in Pediatric Heart Surgery: Impact on Anemia, Transfusion and Complications, a Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT06276608
- Acronym / sponsor ID
- PED_Fe_def
- Conditions
- Iron Deficiencies, Iron Deficiency Anemia, Cardiac Surgical Procedures, Congenital Heart Disease in Children
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Queen Fabiola Children's University HospitalUniversity, hospital or other
- Study start
- 23 Feb 2024 (actual)
- Primary completion
- 20 Apr 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 26 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric cardiac surgery patients | – | Diagnostic Test: Iron statusAll patients who underwent pediatric cardiac surgery in our institution between January 1, 2019 and december 31, 2023 |
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Age groups
- Child
- Study population
- All patients who underwent pediatric cardiac surgery at our institution between January 1, 2019 and December 31, 2023
Key inclusion criteria (1 listed)
- All patients who underwent pediatric cardiac surgery at our institution between January 1, 2019 and December 31, 2023
Key exclusion criteria (2 listed)
- Incomplete medical charts
- Patients who did not consent to the use of their medical data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iron statusIron 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 | Diagnostic test | Pediatric cardiac surgery patients |
Primary outcome
Prevalence of preoperative iron deficiency (%)
Time frame: 24 hours
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, %)
Complications
Time frame: 28 days
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 (%)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Background: PubMed 35722123Gao 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.
- Background: PubMed 33613898Sidhu 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.
- Background: PubMed 34145102Temel 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.
- Background: PubMed 15855050Christen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Iron Deficiencies and Iron Deficiency Anemia, run by Queen Fabiola Children's University Hospital at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Denis Schmartz, MD (+3225553919, denis.schmartz@hubruxelles.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of preoperative iron deficiency (%) (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06276608, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.