Intravenous iron to treat postoperative anaemia in older cardiac surgery patients: a randomized controlled trial (AGE ANAEMIA study)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Sint Antonius Ziekenhuis Stichting

Participant type

Patients

Age range

65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

22 Aug 2024 → ongoing

Decision date (initial)

2024-08-22

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-515920-35-01

EudraCT number

2021-001949-12

ClinicalTrials.gov

NCT04913649

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

To determine the effect of treatment of of postoperative iron deficiency anaemia with intravenous iron on disability at 90 days after cardiac surgery

Secondary objectives 1

1. To evaluate whether administration of postoperative IVI has an effect on change in patient reported outcome measures (PROMs) related to dyspnea symptoms 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.25,26 Further secondary endpoints are the number of postoperative 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 levels at POD 90 will be assessed as an exploratory endpoint.

Conditions and MedDRA coding

iron deficiency anaemia

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1.  Mentally competent with age ≥ 70 years  Elective AVR or CABG surgery (including AVR or CABG surgery combined with rhythm surgery, i.e. maze, pulmonary vein isolation and left auricular ear amputation)  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 1

1.  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)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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 1

1. Postoperative RBC transfusions; Change in reticulocyte hemoglobin content from randomization to hospital discharge; Hb levels at hospital discharge; Hospital complications according to the Nederlandse Hart Registratie (NHR); Days alive and out of hospital at POD 90; Change in PROMs regarding dyspnoea symptoms at POD 90 (assessed with the RDS)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Sint Antonius Ziekenhuis Stichting

Sponsor organisation

Sint Antonius Ziekenhuis Stichting

Address

Koekoekslaan 1

City

Nieuwegein

Postcode

3435 CM

Country

Netherlands

Scientific contact point

Organisation

Sint Antonius Ziekenhuis Stichting

Contact name

Thomas van Dijk

Public contact point

Organisation

Sint Antonius Ziekenhuis Stichting

Contact name

Thomas van Dijk

Locations

1 EU/EEA country · 4 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 3 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications