Intravenous iRon or placebO for aNaeMiA in iNtensive care: The Ironman Randomised Controlled Trial

Phase 2

Active, not recruiting

• Conditions: Anaemia in critical illness; Blood - Anaemia

• Registration Number: ACTRN12612001249842
• Lead Sponsor: Edward Litton

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-11-26
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

1.Admitted to an ICU for less than 48 hours
2.Anticipated to require ICU care beyond the next calendar day
3.Hb less than 100 g/L at any time during the preceding 24 hours
4.Age 18 years or greater

Exclusion Criteria

1.Suspected or confirmed severe sepsis (two or more Systemic Inflammatory Response Syndrome (SIRS) criteria, suspected or confirmed infection, and one or more organ system failure)
2.Serum ferritin greater than 1200ng/ml or transferrin saturation greater than 50%
3.History of haemochromatosis or aceruloplasminaemia
4.Known prior administration of IV iron in the preceding 3 months
5.Jehovah’s Witness or other documented exclusion to receiving blood products
6.Receiving ESA (e.g. epoetin or darbepoeitin) in the 3 months prior to ICU admission
7.Known hypersensitivity to intravenous iron
8.Pregnancy
9.Treatment intent is palliative
10.Death is deemed imminent and inevitable
11.Weight less than 40kg
12.Participating in competing study

Study & Design

• Study Type: Interventional
• Study Design: Not specified