A Phase 3 interventional study of Iron isomaltoside 1000 (Monofer®) and Natriumklorid 9 mg/ml, Fresenius Kabi in Non-anaemic Patients Undergoing Cardiac Surgery, sponsored by Pharmacosmos A/S. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-04-29.
Sponsored by Pharmacosmos A/S · Phase 3, Interventional, and Treatment
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
The role of preoperative haemoglobin as a predictor of short-term and long-term outcomes after cardiac surgery has been well established. Anaemia can impede a patient's ability to recover fully and participate in postoperative rehabilitation. It has been found that patients with a normal haemoglobin level may become anaemic during surgery. An evaluation of patients undergoing cardiac surgery, i.e. CABG, valve or combined CABG-valve procedures showed that there was a decrease in mean haemoglobin level pre-surgery two and four days after surgery. To date, no prospective randomised clinical study in cardiac surgery assessing the effect of intravenous iron supplementation in patients undergoing cardiac surgery has been reported. This prospective, randomized, placebo controlled, double blind study is planned to evaluate the effect of intravenous iron isomaltoside 1000 (Monofer®) in comparison with placebo in non-anaemic patients undergoing cardiac surgery.
Pharmacosmos A/S is the lead sponsor of 36 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
Iron isomaltoside 1000 (Monofer®) - Intravenous Infusion
Drug: Iron isomaltoside 1000 (Monofer®)
Placebo (0.9% sodium saline) - Intravenous infusion
Drug: Natriumklorid 9 mg/ml, Fresenius Kabi
All subjects randomised to this group will receive 1000 mg iron isomaltoside 1000 as a single dose infusion administered over 15 minutes
All subjects randomised to this group will receive an infusion of 100 ml 0.9% sodium chlorid administered over 15 min.
Also known as: 0.9% sodium chlorid.
Change in haemoglobin (Hb) concentrations
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
Time frame: From t=0 to t=4 weeks postoperatively
Change in Hb concentrations
Proportion of patients that are anaemic (women \< 12 g/dL and men \< 13 g/dL) at day 5 and week 4
Time frame: t=0, t=5 days and t=4 weeks
Number of patients in each randomisation group who need blood transfusion and number of transfusions administered
To compare the number of patients who will need blood transfusion and number of transfusions in each randomisation group
Time frame: From t=0 to t=day 5 and t=4 weeks
Change in concentrations of serum ferritin, serum iron and Transferrin Saturation (TfS) TfS, and reticulocytes
From t=0 to t=day 5 and t=4 weeks
Time frame: Change from baseline (preoperatively- the day before surgery or same day) in concentrations of serum ferritin, serum iron and Transferrin Saturation (TfS) TfS, and reticulocytes at 4 weeks and 3 months postoperatively
Number of postoperative days to discharge
To compare the number of days to discharge between the 2 randomisation groups
Time frame: From t=0 to discharge
Changes in New York Heart Association (NYHA) classification
To compare the changes in New York Heart Association (NYHA) classification from baseline to 4 weeks postoperatively
Time frame: From t=0 to t=4 weeks
Number of patients in each randomisation group who experience any study drug related adverse events (AEs/SAEs/SUSARs)
To compare the number of study drug related adverse events (AEs/SAEs/SUSARs) between subjects treated with iron isomaltoside 1000 (Monofer®) infusion and subjects treated with placebo infusion
Time frame: From screening and until completion (t=-7 day and upto t=4 weeks)
Change in Hb
Proportion of patients able to maintain Hb between 9.5 and 12.5 g/dL (both values included) at day 5 and week 4
Time frame: t=0, t=day 5 and t=week 4
This study is completed, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.
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Pharmacosmos A/S