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RECRUITING
NCT04913649
PHASE4

Intravenous Iron to Treat Postoperative Anemia in Older Cardiac Surgery Patients

Sponsor: dr. P. Noordzij

View on ClinicalTrials.gov

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.

Official title: Intravenous Iron to Treat Postoperative Anemia in Older Cardiac Surgery Patients: a Randomized Controlled Trial'

Key Details

Gender

All

Age Range

70 Years - Any

Study Type

INTERVENTIONAL

Enrollment

310

Start Date

2021-09-23

Completion Date

2025-12

Last Updated

2024-12-02

Healthy Volunteers

No

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.

Locations (2)

Amphia Hospital

Breda, Netherlands

St Antonius Hospital

Nieuwegein, Netherlands