The Effects of Intravenous Iron on Mobility in Elderly Patients Following Hip Fracture Surgery (IronHip)

Soren Overgaard

Status and phase: Not yet enrolling; Phase 4

Conditions: Anemia; Hip Fracture

Treatments: Drug: Ferric Derisomaltose; Drug: Saline (NaCl 0,9 %) (placebo)

Study type: Interventional

Funder types: Other

Identifiers

NCT06898814

2024-515116-42-00 (EU Trial (CTIS) Number)

IronHip Trial

Details and patient eligibility

About

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.

Enrollment: 210 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 65 years of age or older
2. Acute proximal femur fracture surgery
3. A hemoglobin measurement ≤6.5 mmol/L (10.5 g/dL) on day 1 to 5 postoperatively
4. Independent prefracture indoor walking ability, indoor NMS ≥ 2
5. Ability to speak and understand Danish
6. Able to provide informed consent on the participants own behalf

Exclusion criteria

1. Known allergy to intravenous iron
2. Residing permanently at a nursing home
3. Hematological conditions with a risk of iron overload e.g. haemochromatosis, hemosiderosis, or where alternative treatments are necessary e.g. haematological malignancies
4. Other contraindication to iron treatment, e.g. severe liver cirrhosis and hepatitis
5. Severe uncontrolled infection as assessed by the responsible clinician (e.g. bacteraemia or sepsis)
6. Plasma sodium levels below 125 or above 150 mmol/L on the day of inclusion
7. Renal replacement therapy
8. Severe dementia assessed by physician
9. Recent intravenous iron injection, 4 weeks prior to surgery
10. Patient declared terminally ill
11. Pathologic Fracture

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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210 participants in 2 patient groups, including a placebo group

Active Investigational Medicinal Product

Active Comparator group

Treatment:

Drug: Ferric Derisomaltose

Placebo

Placebo Comparator group

Treatment:

Drug: Saline (NaCl 0,9 %) (placebo)