CompletedPhase 3

A Prospective, Comparative Study of Intravenous Iron Isomaltoside 1000 (Monofer®) Administered by Infusions to Non-Anaemic Patients Undergoing Elective or Sub-Acute Coronary Artery Bypass Graft, Valve Replacement or a Combination Thereof

Denmark74 participantsStarted 2012-01

Plain-language summary

The purpose of the study is to demonstrate that intravenous iron isomaltoside 1000 (Monofer®) is superior compared to placebo with respect to increasing the haemoglobin level in non-anaemic patients undergoing cardiac surgery

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Men and women, aged more than 18 years.
✓. Subjects undergoing elective or sub-acute CABG, valve replacement or a combination thereof
✓. Female Hb ≥ 12.0 g/dl (7.45 mmol/l), Male Hb ≥ 13.0 g/dl (8.1 mmol/l).
✓. Willingness to participate after informed consent.

Exclusion criteria

✕. Subjects receiving blood transfusion less than 30 days before screening and/or during the elective or sub-acute CABG, valve replacement, or a combination thereof.
✕. Iron overload or disturbances in utilization of iron (e.g. haemochromatosis and haemosiderosis).
✕. Serum Ferritin \> 800 ng/ml.
✕. Known hypersensitivity to any excipients in the investigational drug products.
✕. Patients with a history of multiple allergies.
✕. Decompensated liver cirrhosis and hepatitis.
✕. Alanine Aminotransferase (ALT) \> 3 times normal upper value.
✕. Acute infections (assessed by clinical judgement).

What they're measuring

Change in haemoglobin (Hb) concentrations

Timeframe: From t=0 to t=4 weeks postoperatively

Trial details

NCT IDNCT01563367

SponsorPharmacosmos A/S

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-08

View on ClinicalTrials.gov More Non-anaemic Patients Undergoing Cardiac Surgery trials