Intravenous Iron to Treat Postoperative Anemia in Older Cardiac Surgery Patients

NCT04913649 | Recruiting Phase 4

• 1 other identifier: NL77442.100.21
• Study Type: interventional
• Target: 310
• Locations: 1 country
• Sites: 2

Brief 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

Iron Deficiency Anemia

Keywords

Cardiac surgery; Postoperative anemia; Intravenous iron; Postoperative disability

Outcome Measures

Primary Outcomes (1)

• Disability

  Disability measured by the 12- item World Health Organization Disability Assessment score 2.0 (WHODAS-12). Based on the answers a disability score can be calculated. 0% is no disability and 100% is fully disabled.

  90 days after elective cardiac surgery

Secondary Outcomes (7)

• Change in patient reported outcome measures (PROMs) related to dyspnea

  90 days after elective cardiac surgery

• Change in patient reported outcome measures (PROMs) related to health related quality of life (HRQL)

  90 days after elective cardiac surgery

• Red blood cell transfusions

  +/- 7 days after elective cardiac surgery

• Change in reticulocyte hemoglobin content

  +/- 7 days after elective cardiac surgery

• Change in Hb level

  +/- 7 days after elective cardiac surgery

Other Outcomes (2)

• Functional outcome (exploratory endpoint)

  +/- 90 days after elective cardiac surgery

• Change in Hb level at 90 days (exploratory endpoint)

  +/- 90 days after elective cardiac surgery

Study Arms (2)

Intravenous iron (ferric derisomaltose)

EXPERIMENTAL

The intervention consists of a single dose of ferric derisomaltose (Monofer®) 100 mg/mL solution for infusion (Monofer® is a registered product with a marketing authorization in the Netherlands (RVG number: 103070). Manufacturer: Pharmacosmos A/S, Denmark. Dutch marketing authorization holder: Cablon Medical B.V). The method of administration and dosage of the investigational medication are standard treatment. The ferric derisomaltose dose will calculated for each patient depending on body weight (20mg/kg) and diluted in 250 ml NaCl 0.9%. Treatment takes approximately 60 minutes. Vital signs of the patient will be monitored during administration of the investigational medication and for 30 minutes afterwards

Drug: Ferric Derisomaltose 100 MG/ML

Placebo

PLACEBO COMPARATOR

Single dose of sodium chloride 0.9% (250ml). Treatment takes approximately 60 minutes. Vital signs of the patient will be monitored during administration of the investigational medication and for 30 minutes afterwards

Drug: Sodium chloride

Interventions

Sodium chloride DRUG

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

Also known as: Placebo

Placebo

Ferric Derisomaltose 100 MG/ML DRUG

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

Also known as: Monofer

Intravenous iron (ferric derisomaltose)

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Mentally competent with age ≥ 70 years
• Elective AVR or CABG surgery
• Expected uncomplicated postoperative trajectory, defined as:
• Expected discharge to general ward at POD 1
• Moderate postoperative IDA, defined as:
• Hb between 85 and 110 g/L and
• Ferritin \<100 µg/L or
• Iron saturation (TSAT) \< 20%

You may not qualify if:

• Medical history of iron overload/haemochromatosis
• Medical history of liver cirrhosis or ALT/AST value in blood serum triple of normal value (female patients: ALT \>120, AST \>105 U/L. Male patients: ALT\>150, AST\>135 U/L)
• Severe renal failure (eGFR\<15ml/min/1.73m2)
• Recent treatment with IVI (\<12 weeks prior)
• Serious or severe allergic reaction to IVI in medical history
• Severe asthma or eczema in medical history (atopic constitution)

Sponsors & Collaborators

• dr. P. Noordzij: lead
• Pharmacosmos A/S: collaborator

Study Sites (2)

Amphia Hospital

Breda, Netherlands

RECRUITING

St Antonius Hospital

Nieuwegein, Netherlands

RECRUITING

Related Publications (1)

• Smoor RM, Rettig TCD, Vernooij LM, Groenewegen EM, van Dongen HPA, Noordzij PG. The effect of postoperative intravenous iron in anaemic, older cardiac surgery patients on disability-free survival (AGE ANEMIA study): study protocol for a multi-centre, double-blind, randomized, placebo-controlled trial. Trials. 2023 Oct 26;24(1):693. doi: 10.1186/s13063-023-07725-y.

  PMID: 37885026 DERIVED

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

ferric derisomaltose; Sodium Chloride

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Peter Noordzij, MD, PhD

  St. Antonius Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter Noordzij, MD, PhD

CONTACT

883203000; p.noordzij@antoniusziekenhuis.nl

Rosa Smoor, MD

CONTACT

883203000; r.smoor@antoniusziekenhuis.nl

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Investigator and patient will be blinded for treatment allocation. As the IVI solution is brown and the placebo solution is colourless, the infusion bags and lines will be light-protected in order to prevent identification of the investigational product.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Model Details: Two center randomized controlled trial. Patients will either receive IVI (Monofer) or placebo. Via a computer generated randomization patients will be randomly assigned (1:1) to either a single dose of intravenous ferric derisomaltose (Monofer) 100 mg/mL solution for infusion (intervention group) or intravenous NaCl 0.9% (placebo group) (randomisation with block size 4). Stratification takes surgical intervention (AVR or CABG) and hospital location into account.

Study Record Dates

• First Submitted: May 28, 2021
• First Posted: June 4, 2021
• Study Start: September 23, 2021
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (2)