The aim of this study is to investigate the effects of intravenous (IV) iron therapy compared to alternate-day oral iron treatment and no supplementation in older patients with hip fractures. This study will examine the impact of iron treatment on fatigue, functional decline, fear of falling, cognitive impairment, and quality of life, as well as its effects on iron stores and hemoglobin levels, with the overall goal of improving postoperative rehabilitation. The trial will be conducted on five different hospitals in the Central Region of Denmark (Region Midtjylland).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
528
Intravenous Ferric Derisomaltose shortly after surgery and placebo tablets on alternate days for 90 days
Oral iron sulfate on alternate days for 90 days and IV placebo once shortly after surgery
100 ml Sodium Chloride (NaCl)
Placebo tablets on alternate days for 90 days
Aarhus Univeristy Hospital
Aarhus N, Denmark
Regional Hospital Gødstrup
Herning, Denmark
Regional Hospital Horsens
Horsens, Denmark
Regional Hospital Randers
Randers, Denmark
Regional Hospital Viborg
Viborg, Denmark
Fatigue
Measured by Multidimensional Fatigue Inventory tool (MFI-20). MFI-20 is a questionnaire of 20 questions answered on a 5-point scale from "yes, that is true" (1 point) to "no, that is not true" (5 points). A higher score indicates greater severity of fatigue.
Time frame: Baseline and days 30 and 90 after discharge
Hemoglobin increment
Defined as a change of level of a minimum of 1.24 mmol/L (2 g/dL). The level of hemoglobin will be measured with a venous blood sample
Time frame: Baseline and days 30 and 90 after discharge
Safety profile
Measured as the prevalence and severity of adverse events associated with iron treatment
Time frame: Days 15, 30, 45 and 90 after discharge
Physical function - NMS
New Mobility score (NMS) is used to assess the participant's mobility. The participant will be asked three questions ranging from "no difficult and no walking aid" (3 points) to "not able to at all" (0 points). The score ranges from 0 - 9 points. A higher score indicates a higher level of independent mobility.
Time frame: Baseline and days 30 and 90 after discharge
Physical function - handgrip strength
Handgrip strength is measured by using a dynamometer that measures the pressure made from a hand grip on the dynamometer in kilograms. A higher score indicates higher handgrip strength.
Time frame: Baseline and days 30 and 90 after discharge.
Physical function - 30 second sit-to-stand-test
30 second sit-to-stand-test is used as a parameter for strength, muscle power and dynamic balance. The test is performed by placing a chair with the back against a wall. The participant must be seated on the chair with their arms crossed and are then encouraged to fully stand and sit as many times as possible in 30 seconds. If the arms are used to stand, the score will be 0. A low score indicates low physical ability, and a higher score indicates high physical ability.
Time frame: Baseline and days 30 and 90 after discharge.
Fear of Falling
Measured by Short Fall Efficiency Scale-International which is a 7 questions questionnaire assessing the fear of falling from 7 points (low concern of falling) to 28 points (high concern of falling).
Time frame: Days 30 and 90 after discharge
Cognitive impairment
Measured by Brief Assessment of Impaired Cognition (BASIC). The tool consists of three questions to the patient (0-6 points), word finding (0-5 points), categorized recalling of photos (0-8 points) and lastly three questions to a next of kin (0-6 points). A low score indicates impaired cognition. In cases where no next of kins is available the conversion table is used of an estimated score according to the guidance from the Danish Dementia Research Centre.
Time frame: Baseline and days 30 and 90 after discharge
Quality of life
European Quality of Life - 5 Dimensions (EQ-5D-5L) which is a standardized questionnaire used to evaluate health-related quality of life. There are 5 questions ranging from level 1 - 5 Level 1 indicates: no problems Level 2 indicates: slight problems Level 3 indicates: moderate problems Level 4 indicates: severe problems Level 5 indicates: extreme problems And lastly a visual analogue scale from 0 - 100 where 100 means the best health imaginable and 0 means the worst health imaginable.
Time frame: Baseline and 90 days after discharge
Biochemical iron status - transferrin
p-transferrin (μmol/L) measured by a venous blood sample.
Time frame: Baseline and on days 30 and 90 after discharge
Biochemical iron status - ferritin
p-ferritin (μg/L) measured by a venous blood sample
Time frame: Baseline and on days 30 and 90 after discharge
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.