Evidence map›Paper›PMID 37885026›Full record

ArticleTrials2023

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.

R M Smoor, T C D Rettig, L M Vernooij, E M Groenewegen, H P A van Dongen, P G Noordzij

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04913649 (Intravenous Iron to Treat Postoperative Anemia in Older Cardiac Surgery Patients), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.9field-weighted citation impact, top 22% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04913649 phase4recruitingnot on this map

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

TypeinterventionalSponsordr. P. NoordzijRan2021 to 2026Enrolled310ConditionsIron Deficiency AnemiaArmsFerric Derisomaltose 100 MG/ML, Sodium chloride
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 3 citations in OpenAlex.

  1. Review
  2. Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 3 institutions in 1 country.

R M SmoorDepartment of Anaesthesiology, Intensive Care and Pain Medicine, St. Antonius Hospital, Nieuwegein, The Netherlands.
T C D RettigDepartment of Anaesthesiology, Intensive Care and Pain Medicine, Amphia Hospital, Breda, The Netherlands.
L M VernooijDepartment of Anaesthesiology, Intensive Care and Pain Medicine, St. Antonius Hospital, Nieuwegein, The Netherlands.
E M GroenewegenDepartment of Anaesthesiology, Intensive Care and Pain Medicine, St. Antonius Hospital, Nieuwegein, The Netherlands.
H P A van DongenDepartment of Anaesthesiology, Intensive Care and Pain Medicine, St. Antonius Hospital, Nieuwegein, The Netherlands.
P G NoordzijDepartment of Anaesthesiology, Intensive Care and Pain Medicine, St. Antonius Hospital, Nieuwegein, The Netherlands. p.noordzij@antoniusziekenhuis.nl.ORCID http://orcid.org/0000-0002-7115-8249
University Medical Center Utrecht · NLSt. Antonius Ziekenhuis · NLAmphia Ziekenhuis · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPostoperative anaemia is common in older cardiac surgery patients and often caused by iron deficiency. Anaemia may negatively affect recovery after cardiac surgery. This study aims to determine the efficacy of treatment of postoperative iron deficiency anaemia (IDA) with intravenous iron (IVI) on disability 90 days after cardiac surgery in older patients.

methodsThis is a randomized placebo-controlled double-blind multi-centre trial. In total, 310 patients aged ≥ 70 years with moderate IDA on postoperative day 1 (haemoglobin 85-110 g/L and ferritin concentration < 100 μg/L or iron saturation < 20%) after uncomplicated elective cardiac surgery (aortic valve repair or coronary artery bypass graft surgery) will be included. Patients will be randomly allocated to receive either IVI (ferric derisomaltose) or placebo (sodium chloride 0.9%) on postoperative day 1 in a 1:1 ratio, stratified by centre and type of cardiac surgery. The primary outcome is disability measured by the 12-item World Health Organization Disability Assessment score 2.0 after 90 days. Secondary outcome measures are the number of postoperative red blood cell (RBC) transfusions, change in reticulocyte haemoglobin content (pg) from randomization to hospital discharge, Hb levels at discharge, hospital complications, dyspnoea (assessed with the Rose Dyspnoea Scale) and health-related quality of life (HRQL) (assessed with The Older Persons and Informal Caregivers-Short Form (TOPICS-SF) questionnaire) after 90 days and days alive and out of hospital after 90 days. Lastly, the functional outcomes (e.g. steep ramp or 6-min walk test) and Hb level after 90 days will be assessed as an exploratory endpoint. DISCUSSION: The results of this study will demonstrate whether early treatment of postoperative IDA with IVI improves disability at 90 days in older cardiac surgery patients.

trial registrationClinicalTrials.gov NCT04913649. Registered on June 4, 2021.

Indexed as

AnemiaAnemia, Iron-DeficiencyCardiac Surgical ProceduresAgedAged, 80 and overDyspneaHemoglobinsHumansIronMulticenter Studies as TopicQuality of LifeRandomized Controlled Trials as TopicHemoglobinsIronCardiac surgeryDisabilityElderly patientsIntravenous ironIron deficiency anaemiaRandomized controlled trial

Identifiers

PMID37885026
PMCPMC10601172
OpenAlexW4387966654

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.