WithdrawnPhase 3

Polyglucoferron Compared to i.v. Ferric Carboxymaltose and Oral Iron Substitution in Preoperative Treatment of Iron Deficiency Anaemia in Patients

Stopped: difficult recruitment - redesign in discussion

Germany0Started 2020-05-15

Plain-language summary

Patients with IDA and for whom fast replenishment of iron stores is necessary, e.g. if its not appropriated to postpone surgery, will be identified within 28 to 42 days before surgery. Patients will be randomised to receive either Polyglucoferron intravenously (i.v.), Ferric Carboxymaltose i.v. or oral iron substitution with Ferrous sulfate.

Who can participate

Age range18 Years

SexALL

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Exclusion criteria

✕. known sensitivity to iron or an ingredient of the investigational products
✕. 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

Normalisation or Increase of hemaglobin(Hb)-level

Timeframe: baseline (BL) to day before surgery (visit 4)

Detection of urine iron

Timeframe: approx. 8 hours

Trial details

NCT IDNCT04087993

SponsorDr. Frank Behrens

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-12-31

View on ClinicalTrials.gov More Iron Deficiency Anemia trials