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Intravenous Iron to Treat Postoperative Anemia in Older Cardiac Surgery Patients

NCT04913649 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 310

Last updated 2026-04-27

No results posted yet for this study

Summary

Postoperative anemia is common in cardiac surgery with cardiopulmonary bypass. Iron deficiency delays the recovery from postoperative anemia and may negatively affect the postoperative trajectory of cardiac surgery patients. The objective of the study is to determine the effect of treatment of postoperative iron deficiency anemia with intravenous iron on disability 90 days after surgery. This will be evaluated in a randomized placebo-controlled double blind two-center trial in which 310 elective cardiac surgery patients will be included.

Conditions

Interventions

DRUG

Ferric Derisomaltose 100 MG/ML

Postoperative treatment with a single dose IVI (ferric derisomaltose), with a dose of 20mg/kg in approximately 60 minutes.

DRUG

Sodium chloride

Postoperative treatment with a single dose NaCl 0.9% in approximately 60 minutes.

Sponsors & Collaborators

  • Pharmacosmos A/S

    collaborator INDUSTRY

  • dr. P. Noordzij

    lead OTHER

Principal Investigators

  • Peter Noordzij, MD, PhD · St. Antonius Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-23
Primary Completion
2026-11-30
Completion
2026-12-31

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

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 NCT04913649 on ClinicalTrials.gov