NCT01563367View on ClinicalTrials.gov

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

PHASE3CompletedINTERVENTIONAL
Enrollment

74

Participants

Timeline

Start Date

January 31, 2012

Primary Completion Date

August 31, 2013

Study Completion Date

September 30, 2013

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.

Trial Locations (1)

Unknown

Copenhagen

Sponsors

Lead Sponsor

Pharmacosmos A/S
All Listed Sponsors
collaborator

CRO Max Neeman

UNKNOWN

lead

Pharmacosmos A/S

INDUSTRY

NCT01563367 - 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 | Biotech Hunter | Biotech Hunter