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Search / Trial NCT06898814

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

Launched by SOREN OVERGAARD · Mar 20, 2025

Trial Information

Current as of April 29, 2025

Not yet recruiting

Keywords

Hip Fracture Anemia Iv Iron Mobility Perioperative Optimisation Randomized Controlled Trial

ClinConnect Summary

This clinical trial is exploring whether giving elderly patients intravenous iron after they have surgery for a hip fracture can help them recover better and regain their ability to move around. The researchers believe that intravenous iron might improve mobility, increase hemoglobin levels (which helps carry oxygen in the blood), and reduce feelings of tiredness. Participants in the study will receive either a single dose of intravenous iron or a placebo (a saline solution) within 1 to 5 days after their surgery. The study will involve around 210 participants at three hospitals in Denmark.

To be eligible for this trial, participants need to be 65 years or older, have had surgery for a recent hip fracture, and have a low hemoglobin level shortly after surgery. They should also have been able to walk independently before their injury. However, people with certain medical conditions, allergies to iron, or those living in nursing homes will not be included. If you or a loved one meet these criteria, you may have the opportunity to take part in this important research aimed at improving recovery after hip surgery.

Gender

ALL

Eligibility criteria

  • 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

About Soren Overgaard

Soren Overgaard is a dedicated clinical trial sponsor with a commitment to advancing medical research and improving patient outcomes. With extensive expertise in clinical development and a focus on innovative therapeutic solutions, Overgaard leads initiatives that prioritize patient safety and regulatory compliance. The organization is renowned for its collaborative approach, working closely with healthcare professionals, regulatory bodies, and research institutions to facilitate the efficient design and execution of clinical studies. Through rigorous methodologies and a commitment to scientific integrity, Soren Overgaard strives to contribute to the future of healthcare by bringing new therapies to market and enhancing the understanding of various medical conditions.

Locations

Copenhagen Nv, , Denmark

Herlev, , Denmark

Odense C, , Denmark

Patients applied

0 patients applied

Trial Officials

Nicolas Tekin Jones, MD

Principal Investigator

Copenhagen University Hospital Bispebjerg, Department of Orthopaedic Surgery and Traumatology

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported