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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
210
The active intervention is a single dose of Ferric Derisomaltose, 20mg/kg body weight, diluted in 100 mL isotonic sodium chloride 0.9%
Single dose of 100 mL isotonic sodium chloride 0.9%
Department of Orthopedic Surgery and Traumatology, Bispebjerg, Copenhagen University Hospital
Copenhagen NV, Denmark
RECRUITINGDepartment of Orthopedic Surgery and Traumatology, Herlev, Copenhagen University Hospital
Herlev, Denmark
RECRUITINGDepartment of Orthopaedic Surgery, Odense and Svendborg University Hospital
Odense C, Denmark
RECRUITINGNew Mobility Score (NMS)
The primary outcome is to compare the effect of a single dose of FDI (20 mg/kg body weight) relative to placebo on patients' recovery of functional mobility measured with New Mobility Score. New Mobility Score is a validated patient reported outcome measurement 0-9-point score for hip fracture patients, with 9 point equal to a fully independent indoor, outdoor and during shopping walking ability and 0 point, indicating no walking ability. Higher scores indicate a better outcome.
Time frame: Measured as the change from baseline (reported as pre-fracture NMS) in the New Mobility Score after 4, 6 and 12 weeks
Hemoglobin
Time frame: Measured at baseline, 6 and 12 weeks after intervention.
Red blood cell transfusion requirement
This will be measured by the proportion of patients who receive at least one red blood cell unit and the amounts of units per patient
Time frame: Measured on postoperative day (POD) 7 and POD 30
Fatigue, assessed using the Verbal Rating Scale for Fatigue (F-VRS)
Fatigue will be assessed using the Verbal Rating Scale for Fatigue (F-VRS). This scale, ranging from 0 to 4, measures fatigue in hip fracture patients, where 0 indicates no fatigue and 4 represents extreme fatigue.
Time frame: Measured at baseline, 4, 6 and 12 weeks after intervention.
Quality of life with EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L )
The EQ-5D-5L questionnaire measures health-related quality of life across five dimensions, with scores ranging from 1 (no problems) to 5 (extreme problems). Higher scores indicate worse outcomes, reflecting greater health issues.
Time frame: 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)
The EQ VAS 0-100 (range) is a visual analogue scale where 0 represents the worst imaginable health state and 100 represents the best. Higher scores on the EQ VAS indicate a better health outcome.
Time frame: 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)
Short Falls Efficacy Scale International (Short-FES-I) measures concern about falling during various activities, with scores ranging from 7 (no concern about falling) to 28 (severe concern about falling). Higher scores indicate greater concern about falling.
Time frame: Measured at baseline and at 6 and 12 weeks after intervention.
30 second Sit-to-Stand-Test (STS)
Participants are encouraged to stand and fully sit as many times as possible within 30 seconds, with correct form monitored by the tester. If a participant uses their arms, they score a 0, and only correctly executed stands are counted. This test assesses a wide range of ability levels. Lower score indicates worse outcome.
Time frame: Measured at baseline, 6 and 12 weeks
Activity of daily living, asessed with Barthel Index 20
Barthel 20 Index measures a patient's level of independence in daily activities, with scores ranging from 0 (complete dependence) to 20 (complete independence). Higher scores indicate a better outcome, reflecting greater independence.
Time frame: Measured as a retrograde baseline and at 6 and 12 weeks after intervention
Pain, assessed using the Verbal Rating Scale for pain
Hip fracture-related pain will be assessed using the Verbal Rating Scale for Pain, which ranges from 0 to 4. A score of 0 indicates no pain, while a score of 4 represents unbearable or the worst imaginable pain
Time frame: Measured at baseline and at 6 and 12 weeks after intervention
Days alive and at home up to 30 (DAH30)
The DAH30 is determined using a combination of electronic medical records (obtaining length of stay) and direct participant inquiries at the 6 week follow up
Time frame: Measured at 6 weeks after intervention.
Serious adverse event (SAE)
SAE defined following the ICH - GCP guidelines
Time frame: Will be assessed up to the 6 weeks follow up
Mortality
The time of death is determined using validated registry-based data, from which survival rates, as well as 30-day and 90-day mortality rates, are calculated.
Time frame: 90 days
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