Intravenous Iron to Treat Postoperative Anemia in Older Cardiac Surgery Patients

Phase

Condition

Anemia

Treatment

Ferric Derisomaltose 100 MG/ML

Sodium chloride

Clinical Study ID

NCT04913649

NL77442.100.21

Ages > 70
All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Mentally competent with age ≥ 70 years
Elective AVR or CABG surgery
Expected uncomplicated postoperative trajectory, defined as:
No inotropic agents or ventilation at time of final inclusion (POD 1)
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%

Exclusion

Exclusion Criteria:

Medical history of iron overload/haemochromatosis
Medical history of liver cirrhosis or ALT/AST value in blood serum triple of normalvalue (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)

Study Design

Ferric Derisomaltose 100 MG/ML

September 23, 2021

December 31, 2025

Study Description

Rationale: 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.

Objective: To determine the effect of treatment of postoperative iron deficiency anemia (IDA) with intravenous iron (IVI) on disability 90 days after surgery.

Study design: Randomized placebo-controlled double blind two-center trial

Study population: 310 elderly patients (≥70 years) with moderate postoperative IDA on postoperative day (POD) 1 (hemoglobin (Hb) 85 - 110 g/L, ferritin concentration < 100 µg/L or iron saturation <20%) after uncomplicated elective cardiac surgery (aortic valve repair (AVR) and coronary artery bypass graft (CABG) surgery).

Intervention: Postoperative treatment with a single dose IVI (ferric derisomaltose, Monofer®, N = 155) compared to postoperative treatment with sodium chloride (NaCL) 0.9% (placebo, N = 155).

Main study endpoints: 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 endpoints are change in patient reported outcome measures (PROMs) related to dyspnea (assessed with the Rose Dyspnea Score (RDS)) and to health-related quality of life (HRQL) (assessed with The Older Persons and Informal Caregivers-Short Form (TOPICS-SF) questionnaire) at POD 90, the number of postoperative red blood cell (RBC) transfusions, change in reticulocyte hemoglobin content (pg) from randomization to hospital discharge, Hb levels at discharge, hospital complications and days alive and out of hospital at 90 days. Lastly, the difference in functional outcomes (e.g. steep ramp or 6-minute walk test) and Hb value at POD 90 will be assessed as an exploratory endpoint.

Connect with a study center

Amphia Hospital
Breda,
Netherlands
Active - Recruiting
St Antonius Hospital
Nieuwegein,
Netherlands
Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.