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

Официальное название

The Effects of Intravenous Iron on Mobility in Elderly Patients Following Hip Fracture Surgery: a Multicentre, Parallel Group, Randomised Controlled Trial

Обзор

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.

Вмешательства

• Препарат Ferric Derisomaltose
  The active intervention is a single dose of Ferric Derisomaltose, 20mg/kg body weight, diluted in 100 mL isotonic sodium chloride 0.9%
• Препарат Saline (NaCl 0,9 %) (placebo)
  Single dose of 100 mL isotonic sodium chloride 0.9%

Первичные конечные точки

• New Mobility Score (NMS) [Срок оценки: Measured as the change from baseline (reported as pre-fracture NMS) in the New Mobility Score after 4, 6 and 12 weeks]

Вторичные конечные точки (12)

• Hemoglobin [Срок оценки: Measured at baseline, 6 and 12 weeks after intervention.]
• Red blood cell transfusion requirement [Срок оценки: Measured on postoperative day (POD) 7 and POD 30]
• Fatigue, assessed using the Verbal Rating Scale for Fatigue (F-VRS) [Срок оценки: Measured at baseline, 4, 6 and 12 weeks after intervention.]
• Quality of life with EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L ) [Срок оценки: Measured as a retrograde baseline the weeks prior to admission and at 6 and 12 weeks after intervention]
• EuroQol Visual Analogue Scale (EQ VAS 0-100) [Срок оценки: Measured as a retrograde baseline the weeks prior to admission and at 6 and 12 weeks after intervention]
• Fear of falls measured with, Short Falls Efficacy Scale International (Short-FES-I) [Срок оценки: Measured at baseline and at 6 and 12 weeks after intervention.]
• 30 second Sit-to-Stand-Test (STS) [Срок оценки: Measured at baseline, 6 and 12 weeks]
• Activity of daily living, asessed with Barthel Index 20 [Срок оценки: Measured as a retrograde baseline and at 6 and 12 weeks after intervention]
• Pain, assessed using the Verbal Rating Scale for pain [Срок оценки: Measured at baseline and at 6 and 12 weeks after intervention]
• Days alive and at home up to 30 (DAH30) [Срок оценки: Measured at 6 weeks after intervention.]
• Serious adverse event (SAE) [Срок оценки: Will be assessed up to the 6 weeks follow up]
• Mortality [Срок оценки: 90 days]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Дания · 3 центра

• Department of Orthopedic Surgery and Traumatology, Bispebjerg, Copenhagen University Hospi — Copenhagen NV
• Department of Orthopedic Surgery and Traumatology, Herlev, Copenhagen University Hospital — Herlev
• Department of Orthopaedic Surgery, Odense and Svendborg University Hospital — Odense C

Публикации

• Jones NT, Kristensen MT, Christensen R, Alva-Jorgensen JP, Berger AL, Eggertsen MA, Bang Foss N, Henriksen M, Jensen TG, Kidholm K, Lunn TH, Nielsen MS, Palm H, Petersen PB, Stampe H, Viberg B, Overgaard S, Aasbrenn M. The effects of intravenous iron on mobility in older adults following hip fracture surgery: protocol for a multicentre, parallel group, randomised controlled trial - the IronHip tri PMID 42442814

Идентификаторы

NCT: NCT06898814 · IronHip Trial · 2024-515116-42-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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