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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

NCT01563367 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2014-04-29

No results posted yet for this study

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

Conditions

  • Non-anaemic Patients Undergoing Cardiac Surgery

Interventions

DRUG

Iron isomaltoside 1000 (Monofer®)

All subjects randomised to this group will receive 1000 mg iron isomaltoside 1000 as a single dose infusion administered over 15 minutes

DRUG

Natriumklorid 9 mg/ml, Fresenius Kabi

All subjects randomised to this group will receive an infusion of 100 ml 0.9% sodium chlorid administered over 15 min.

Sponsors & Collaborators

  • CRO Max Neeman

    collaborator UNKNOWN

  • Pharmacosmos A/S

    lead INDUSTRY

Principal Investigators

  • Lars Lykke Thomsen · Pharmacosmos A/S

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2013-08-31
Completion
2013-09-30

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01563367 on ClinicalTrials.gov