IRONCARE: Iron Treatment in Older Patients With Hip Fractures
IRONCARE: Iron Treatment in Older Patients With Hip Fractures - A Double-blinded Placebo-controlled Randomized Trial
The aim of this study is to investigate the effects of intravenous (IV) iron therapy compared to alternate-day oral iron treatment and no supplementation in older patients with hip fractures. This study will examine the impact of iron treatment on fatigue, functional decline, fear of falling, cognitive impairment, and quality of life, as well as its effects on iron stores and hemoglobin levels, with the overall goal of improving postoperative rehabilitation.
The trial will be conducted on five different hospitals in the Central Region of Denmark (Region Midtjylland).
Visão geral do estudo
Status
Condições
Tipo de estudo
Inscrição (Estimado)
Estágio
- Fase 4
Contactos e Locais
Contato de estudo
- Nome: Ole Vincent Ancker, MD
- Número de telefone: +4551322385
- E-mail: ole.ancker@rm.dk
Estude backup de contato
- Nome: Merete Gregersen, ph.d.
- E-mail: meregreg@rm.dk
Locais de estudo
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Aarhus N, Dinamarca, 8200
- Aarhus Univeristy Hospital
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Contato:
- Ole Vincent Ancker, MD
- Número de telefone: +4551352385
- E-mail: ole.ancker@rm.dk
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Herning, Dinamarca, 7400
- Regional Hospital Gødstrup
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Contato:
- Ole Vincent Ancker, MD
- Número de telefone: +4551352385
- E-mail: ole.ancker@rm.dk
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Horsens, Dinamarca, 8700
- Regional Hospital Horsens
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Contato:
- Ole Vincent Ancker, MD
- Número de telefone: +4551352385
- E-mail: ole.ancker@rm.dk
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Randers, Dinamarca, 8930
- Regional Hospital Randers
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Contato:
- Ole Vincent Ancker, MD
- Número de telefone: +4551352385
- E-mail: ole.ancker@rm.dk
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Viborg, Dinamarca, 8800
- Regional Hospital Viborg
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Contato:
- Ole Vincent Ancker, MD
- Número de telefone: +4551352385
- E-mail: ole.ancker@rm.dk
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Hip fracture (ICD-10 codes: DS720, DS721 and DS722)
- Low energy trauma
- Age ≥ 75 years
- Hemoglobin ≤7.0 mmol/L (11 g/dL) during hospital admission
Exclusion Criteria:
- Pathological fracture
- Periprosthetic fracture
- Inability to understand or speak Danish
- Dysphagia and thus inability to swallow study medication
- Signs of iron overload, hemochromatosis, or hemosiderosis
- Liver disease (cirrhosis or hepatitis) and transaminase levels >3 times upper limit of normal
- Known allergy to iron formulations
- Severe asthma
- Severe hypophosphatemia: <0.35 mmol/L
- Patients already receiving iron supplementation that cannot be paused for the study period
- Cognitive impairment that results in either memantine-treatment or a Short Portable Mental Status Questionnaire (SPMSQ) score > 4
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Comparador Ativo: IV Iron
Intravenous iron once and placebo tablets on alternate days for 90 days
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Intravenous Ferric Derisomaltose shortly after surgery and placebo tablets on alternate days for 90 days
Placebo tablets on alternate days for 90 days
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Comparador Ativo: Oral Iron
Intravenous sodium chloride once and ferro sulfate tablets on alternate days for 90 days
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Oral iron sulfate on alternate days for 90 days and IV placebo once shortly after surgery
100 ml Sodium Chloride (NaCl)
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Comparador de Placebo: Placebo
Intravenous sodium chloride once and placebo tablets on alternate days for 90 days
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Placebo tablets on alternate days for 90 days
100 ml Sodium Chloride (NaCl)
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Fatigue
Prazo: Baseline and days 30 and 90 after discharge
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Measured by Multidimensional Fatigue Inventory tool (MFI-20).
MFI-20 is a questionnaire of 20 questions answered on a 5-point scale from "yes, that is true" (1 point) to "no, that is not true" (5 points).
A higher score indicates greater severity of fatigue.
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Baseline and days 30 and 90 after discharge
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Hemoglobin increment
Prazo: Baseline and days 30 and 90 after discharge
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Defined as a change of level of a minimum of 1.24 mmol/L (2 g/dL).
The level of hemoglobin will be measured with a venous blood sample
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Baseline and days 30 and 90 after discharge
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Safety profile
Prazo: Days 15, 30, 45 and 90 after discharge
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Measured as the prevalence and severity of adverse events associated with iron treatment
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Days 15, 30, 45 and 90 after discharge
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Physical function - NMS
Prazo: Baseline and days 30 and 90 after discharge
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New Mobility score (NMS) is used to assess the participant's mobility. The participant will be asked three questions ranging from "no difficult and no walking aid" (3 points) to "not able to at all" (0 points). The score ranges from 0 - 9 points. A higher score indicates a higher level of independent mobility. |
Baseline and days 30 and 90 after discharge
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Physical function - handgrip strength
Prazo: Baseline and days 30 and 90 after discharge.
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Handgrip strength is measured by using a dynamometer that measures the pressure made from a hand grip on the dynamometer in kilograms.
A higher score indicates higher handgrip strength.
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Baseline and days 30 and 90 after discharge.
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Physical function - 30 second sit-to-stand-test
Prazo: Baseline and days 30 and 90 after discharge.
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30 second sit-to-stand-test is used as a parameter for strength, muscle power and dynamic balance. The test is performed by placing a chair with the back against a wall. The participant must be seated on the chair with their arms crossed and are then encouraged to fully stand and sit as many times as possible in 30 seconds. If the arms are used to stand, the score will be 0. A low score indicates low physical ability, and a higher score indicates high physical ability. |
Baseline and days 30 and 90 after discharge.
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Fear of Falling
Prazo: Days 30 and 90 after discharge
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Measured by Short Fall Efficiency Scale-International which is a 7 questions questionnaire assessing the fear of falling from 7 points (low concern of falling) to 28 points (high concern of falling).
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Days 30 and 90 after discharge
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Quality of life
Prazo: Baseline and 90 days after discharge
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European Quality of Life - 5 Dimensions (EQ-5D-5L) which is a standardized questionnaire used to evaluate health-related quality of life.
There are 5 questions ranging from level 1 - 5 Level 1 indicates: no problems Level 2 indicates: slight problems Level 3 indicates: moderate problems Level 4 indicates: severe problems Level 5 indicates: extreme problems And lastly a visual analogue scale from 0 - 100 where 100 means the best health imaginable and 0 means the worst health imaginable.
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Baseline and 90 days after discharge
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Cognitive impairment
Prazo: Baseline and days 30 and 90 after discharge
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Measured by Brief Assessment of Impaired Cognition (BASIC). The tool consists of three questions to the patient (0-6 points), word finding (0-5 points), categorized recalling of photos (0-8 points) and lastly three questions to a next of kin (0-6 points). A low score indicates impaired cognition. In cases where no next of kins is available the conversion table is used of an estimated score according to the guidance from the Danish Dementia Research Centre. |
Baseline and days 30 and 90 after discharge
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Biochemical iron status - transferrin
Prazo: Baseline and on days 30 and 90 after discharge
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p-transferrin (μmol/L) measured by a venous blood sample.
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Baseline and on days 30 and 90 after discharge
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Biochemical iron status - ferritin
Prazo: Baseline and on days 30 and 90 after discharge
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p-ferritin (μg/L) measured by a venous blood sample
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Baseline and on days 30 and 90 after discharge
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Colaboradores e Investigadores
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Ferimentos e Lesões
- Lesões nas pernas
- Doenças Hematológicas
- Fraturas, Osso
- Fraturas Femorais
- Lesões do quadril
- Condições Patológicas, Sinais e Sintomas
- Sinais e sintomas
- Doenças hemic e linfáticas
- Fadiga
- Fraturas de quadril
- Anemia
- Produtos químicos inorgânicos
- Elementos
- Metais
- Metais, pesados
- Elementos de transição
- Ferro
- sulfato ferroso
- Derisomaltose férrica
Outros números de identificação do estudo
- IRONCARE-2026
- 2026-526949-94-00 (Ctis)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
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