Intravenous Iron to Treat Postoperative Anemia in Older Cardiac Surgery Patients

Iron Deficiency Anemia Clinical Trial

— AGE-ANEMIA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04913649
• Other study ID #: NL77442.100.21
• Status: Recruiting
• Phase: Phase 4
• Start date: September 23, 2021
• Est. completion date: December 2025

Study information

• Verified date: March 2023
• Source: St. Antonius Hospital
• Contact: Peter Noordzij, MD, PhD
• Phone: 883203000
• Email: p.noordzij[@]antoniusziekenhuis.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 310
• Est. completion date: December 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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 Criteria:

• 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)

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Iron Deficiency Anemia

Intervention

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

Locations

Country	Name	City	State
Netherlands	Amphia Hospital	Breda
Netherlands	St Antonius Hospital	Nieuwegein

Sponsors (2)

Lead Sponsor	Collaborator
dr. P. Noordzij	Pharmacosmos A/S

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Functional outcome (exploratory endpoint)	As part of routine care, patients are offered a cardiac revalidation program supervised by a physical therapist after hospital discharge (POD 90). To assess whether patients can safely start exercising, a functional test is performed (e.g. steep ramp or 6-minute walk test). For this study, the results of these tests will be requested to assess functional capacity after surgery	+/- 90 days after elective cardiac surgery
Other	Change in Hb level at 90 days (exploratory endpoint)	Laboratory results (i.e. Hb values if available) assessed by the treating cardiologist are requested when patients have visited the hospital during follow-up	+/- 90 days after elective cardiac surgery
Primary	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	Change in patient reported outcome measures (PROMs) related to dyspnea	PROMS related to dyspnea are assessed with the Rose Dyspnea Scale (RDS). Rose Dyspnea Scale scores range from 0 to 4 with higher scores indicating more dyspnea with common activities.	90 days after elective cardiac surgery
Secondary	Change in patient reported outcome measures (PROMs) related to health related quality of life (HRQL)	HRQL is assessed with The Older Persons and Informal Caregivers-Short Form (TOPICS-SF) questionnaire. The TOPIC-SF is comprised of 22 items in 7 domains of health and well-being. Scores in the different domains ranges from 0 to 5, higher scores indicating diminished quality of life.	90 days after elective cardiac surgery
Secondary	Red blood cell transfusions	Number of red blood cell transfusions during hospital stay	+/- 7 days after elective cardiac surgery
Secondary	Change in reticulocyte hemoglobin content	Change in reticulocyte hemoglobin content from randomization to hospital discharge	+/- 7 days after elective cardiac surgery
Secondary	Change in Hb level	Change in Hb level from randomization to hospital discharge	+/- 7 days after elective cardiac surgery
Secondary	Postoperative complications	Postoperative complications during hospital stay	+/- 7 days after elective cardiac surgery
Secondary	Days alive and out of hospital	Days alive and out of hospital	90 days after elective cardiac surgery