Examination of effictiveness of iron containing infusion in preventing anemia after heart surgery in children

Double blind randomized study to evaluate the efficiency of intravenous ferric carboxymaltose in preventing anemia after cardiopulmonary bypass in children with congenital heart disease - Anemiastudy

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-002107-16-AT

Enrollment

100

Registered

2014-07-21

Start date

2014-10-09

Completion date

Unknown

Last updated

2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia after cardiopulmonary bypass in children with congenital heart disease MedDRA version: 17.0 Level: HLT Classification code 10002042 Term: Anaemia deficiencies System Organ Class: 100000004851

Interventions

Trade Name: Ferinject Product Name: Ferinject Product Code: 1-27299 Pharmaceutical Form: Infusion INN or Proposed INN: FERRIC CARBOXYMALTOSE CAS Number: 9007-72-1 Current Sponsor code: Vifor Int Other

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: age 0-18 years open heart surgery with cardiopulmonary bypass informed parental consent 0-2 months hemoglobin under 16g/dl 3months - 6 years hemoglobin under 12 g/dl 6 - 18 years under hemoglobin under 13,5g/dl Are the trial subjects under 18? yes Number of subjects for this age range: 100 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: re do operation postoperative extracorporal membrane oxgenation massive transfusion preceeding intravenous iron therapy 0-2 months hemoglobin over 16g/dl 3 months to 6 years over 12g/dl 6 to 18 years over 13,5g/dl missing informed consent

Design outcomes

Primary

Measure	Time frame
Main Objective: More rapid increase of hemoglobin triggered by ferric carboxymaltose than with placebo;Secondary Objective: number of red cell transfusion needed;Primary end point(s): postoperative increase of hemoglobin;Timepoint(s) of evaluation of this end point: 21st postoperative day	—

Secondary

Measure	Time frame
Secondary end point(s): numbers of red cell transfusions;Timepoint(s) of evaluation of this end point: 21st postoperative day	—

Countries

Austria

Contacts

Public ContactAnesthesiology and Intensive Care

General Hospital Linz

jens.meier@akh.linz.at004373278062158

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026