Intravenous iron to treat postoperative anaemia in older cardiac surgery patients: a randomized controlled trial (AGE ANAEMIA study)

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-515920-35-01

Enrollment

310

Registered

2024-08-22

Start date

Unknown

Completion date

Unknown

Last updated

2024-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

iron deficiency anaemia

Brief summary

Primary endpoint is disability as measured by the 12- item World Health Organization Disability Assessment score 2.0 (WHODAS-12) at POD 90 after elective cardiac surgery.

Detailed description

Postoperative RBC transfusions; Change in reticulocyte hemoglobin content from randomization to hospital discharge; Hb levels at hospital discharge; Hospital complications according to the Nederlandse Hart Registratie (NHR); Days alive and out of hospital at POD 90; Change in PROMs regarding dyspnoea symptoms at POD 90 (assessed with the RDS)

Interventions

DRUGMonofer 100 mg/ml oplossing voor injectie/infusie

DRUG0.9% Sodium Chloride Intravenous Infusion Solution

Eligibility

Sex/Gender

All

Age

65 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Primary endpoint is disability as measured by the 12- item World Health Organization Disability Assessment score 2.0 (WHODAS-12) at POD 90 after elective cardiac surgery.	—

Secondary

Measure	Time frame
Postoperative RBC transfusions; Change in reticulocyte hemoglobin content from randomization to hospital discharge; Hb levels at hospital discharge; Hospital complications according to the Nederlandse Hart Registratie (NHR); Days alive and out of hospital at POD 90; Change in PROMs regarding dyspnoea symptoms at POD 90 (assessed with the RDS)	—

Countries

Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026