Examination of effictiveness of iron containing infusion in preventing anemia after heart surgery in childre
- Conditions
- Anemia after cardiopulmonary bypass in children with congenital heart diseaseMedDRA version: 17.0Level: HLTClassification code 10002042Term: Anaemia deficienciesSystem Organ Class: 100000004851Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2014-002107-16-AT
- Lead Sponsor
- General Hospital Linz
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Secondary end point(s): numbers of red cell transfusions;Timepoint(s) of evaluation of this end point: 21st postoperative day