drugset / Trial / NCT03817957
Postoperative i.v. Iron Substitution in Patients With Diagnosed Iron Deficiency
Phase 3
Completed
187 enrolled
Prof. Dr. Frank Behrens
IRON4U · collabUniversity Hospital Frankfurt Institute for Biostatistics & Mathematical Modelling · collabUniversity Hospital Frankfurt, Department of Anaesthesiology · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
Iron deficiency anaemia (IDA) in postoperative patients with confirmed preoperative iron deficiency (ID) in a population with planned major surgery who need fast replenishment of iron as judged by the treating physician will be treated with i.v. iron using Polyglucoferron, Ferric Carboxymaltose or oral iron
Timeline
- Start
- 2018-09-18
- Primary completion
- 2023-12-04
- Completion
- 2024-10-21
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Ferric carboxymaltose | Other / unclassified | 500 mg | Intravenous |
| Comparator | Ferric carboxymaltose | Other / unclassified | 1000 mg | Intravenous |
| Comparator | Ferric carboxymaltose | Other / unclassified | 2000 mg | Intravenous |
| Comparator | Ferrous Sulfate | Diagnostic / imaging agent | 50 mg | Oral |
| Comparator | Ferrous Sulfate | Diagnostic / imaging agent | 200 mg | Oral |
| Subject | Polyglucoferron | Unknown | 500 mg | Intravenous |
| Subject | Polyglucoferron | Unknown | 2000 mg | Intravenous |