CompletedPhase 3

Postoperative i.v. Iron Substitution in Patients With Diagnosed Iron Deficiency

Germany187 participantsStarted 2018-09-18

Plain-language 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

Who can participate

Age range18 Years

SexALL

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Exclusion criteria

✕. known sensitivity to iron or an ingredient of the investigational products
✕. Significant history of systemic allergic reactions
✕. Haemachromatosis, thalassemia or TSAT \>50% as indicator of iron overload
✕. Acute or chronic intoxication
✕. Infection (patient on non-prophylactic antibiotics)
✕. Chronic liver disease and/or screening Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) above three times the upper limit of the normal range
✕. according to Summary of product characteristics (SmPC)
✕. hypersensitivity to any ingredient in the formulation

What they're measuring

Proportion of patients who achieve normalized Hb-levels or increased Hb of at least 1.5 g/dl

Timeframe: Baseline to approximately 30 days post-baseline (visit 4)

pre post difference of volumen-corrected urine iron levels

Timeframe: urine sampled prior to administration and approximately 1 to 8 hours post-baseline

Trial details

NCT IDNCT03817957

SponsorProf. Dr. Frank Behrens

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12-04

View on ClinicalTrials.gov More Iron Deficiency Anemia trials