Overview
The primary aim of this clinical trial is to investigate the effects of intravenous iron on recovery in mobility compared to the pre-fracture level in patients with a hip fracture
The main questions it aims to answer are:
It is hypothesize that intravenous iron will enhance gains in mobility and hereby recovery of mobility, increase hemoglobin (Hgb), lower fatigue, have a positive effect on skeletal muscles in the weeks and months after administration.
The primary objective is to compare the effect of a single dose of ferric derisomaltose (FDI) (20 mg/kg body weight) relative to placebo on patients' recovery of functional mobility, measured as the change from baseline in the New Mobility Score.
Participants will:
- Receive either a single dose of intravenous FDI (20 mg/kg body weight) (and saline) or placebo (saline) at 1-5 days after surgery.
This trial will be conducted at three hospitals in Denmark, involving an anticipated 210 participants.
Eligibility
Inclusion Criteria:
- 65 years of age or older
- Acute proximal femur fracture surgery
- A hemoglobin measurement ≤6.5 mmol/L (10.5 g/dL) on day 1 to 5 postoperatively
- Independent prefracture indoor walking ability, indoor NMS ≥ 2
- Ability to speak and understand Danish
- Able to provide informed consent on the participants own behalf
Exclusion Criteria:
- Known allergy to intravenous iron
- Residing permanently at a nursing home
- Hematological conditions with a risk of iron overload e.g. haemochromatosis, hemosiderosis, or where alternative treatments are necessary e.g. haematological malignancies
- Other contraindication to iron treatment, e.g. severe liver cirrhosis and hepatitis
- Severe uncontrolled infection as assessed by the responsible clinician (e.g. bacteraemia or sepsis)
- Plasma sodium levels below 125 or above 150 mmol/L on the day of inclusion
- Renal replacement therapy
- Severe dementia assessed by physician
- Recent intravenous iron injection, 4 weeks prior to surgery
- Patient declared terminally ill
- Pathologic Fracture