Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
ITACS: Intravenous Iron for Treatment of Anaemia Before Cardiac Surgery
NCT02632760Phase 4
Key facts
- Status
- Completed
- Start
- Jul 2016
- Primary completion
- Apr 2024
- Countries
- 1
- Modality
- Small Molecules
- Conditions
- anemia
01
Overview
Phase 4, randomised, double-blind trial in anemia comparing Ferric carboxymaltose with Placebo (2 arms). Primary endpoint: Days alive and out of hospital at 90 days. Started Jul 2016; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Ferric carboxymaltose
Ferric carboxymaltose 1000 mg or Iron isomaltoside 1000 mg given Intravenously
Placebo
Placebo intravenous infusion
03
Who it enrols
Patients with anemia undergoing elective cardiac surgery, available to receive trial drug 1-10 weeks prior to surgery. Excludes pregnant women, those with known hypersensitivity, haemoglobinopathy/thalassaemia, bone marrow disease, haemochromatosis, on renal dialysis, or who received erythropoietin or IV iron in the previous 4 weeks.
04
Endpoints
Primary
Days alive and out of hospital
Secondary
Correction of anemia measured by hemoglobin
Intensive care stay
Hospital stay
Disability-free survival
90-day survival
Units of allogeneic blood transfused
Person's wellbeing
Cost-effectiveness
Beyond the preview
Go deeper on NCT02632760.
Full results, competitive context and analysis are in the Gosset platform.
Competitive context
Available in the Gosset platform where reported.
Bring the full picture into focus.
See how Gosset can support your research on NCT02632760.