IRONCARE: Iron Treatment in Older Patients With Hip Fractures
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age75+
SponsorUniversity of Aarhus
About this 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).
Eligibility criteria
Qualifiers
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
Disqualifiers
Pathological fracture
Periprosthetic fracture
Inability to understand or speak Danish
Dysphagia and thus inability to swallow study medication
Trial design
Treatments tested in this trial
- Ferric Derisomaltose
- Oral Iron (Ferrous sulphate)
- Placebo IV
- Placebo Tablets
Treatment groups
528 Participants
are divided into 3 treatment groupsSponsors and collaborators
University of Aarhus
Lead sponsor
Region MidtJylland Denmark
Collaborator
Viborg Regional Hospital
Collaborator
Gødstrup Hospital
Collaborator
Aarhus University Hospital
Collaborator
Randers Regional Hospital
Collaborator
Regionshospitalet Horsens
Collaborator
Source ClinicalTrials.gov