Anemia, Hip Fracture, Iron, Placebo - Control
Conditions
Keywords
Hip fracture, Anemia, iron, Intravenous iron, mobility, fatigue, hemoglobin, RCT, Placebo
Brief summary
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).
Interventions
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
DRUGPlacebo IV
100 ml Sodium Chloride (NaCl)
DRUGPlacebo Tablets
Placebo tablets on alternate days for 90 days
Sponsors
University of Aarhus
Region MidtJylland Denmark
Viborg Regional Hospital
Gødstrup Hospital
Aarhus University Hospital
Randers Regional Hospital
Regionshospitalet Horsens
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
75 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Hip fracture (ICD-10 codes: DS720, DS721 and DS722) * Low energy trauma * Age ≥ 75 years * Hemoglobin ≤7.0 mmol/L (11 g/dL) during hospital admission
Exclusion criteria
* Pathological fracture * Periprosthetic fracture * Inability to understand or speak Danish * Dysphagia and thus inability to swallow study medication * Signs of iron overload, hemochromatosis, or hemosiderosis * Liver disease (cirrhosis or hepatitis) and transaminase levels \>3 times upper limit of normal * Known allergy to iron formulations * Severe asthma * Severe hypophosphatemia: \<0.35 mmol/L * Patients already receiving iron supplementation that cannot be paused for the study period * Cognitive impairment that results in either memantine-treatment or a Short Portable Mental Status Questionnaire (SPMSQ) score \> 4
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue | Baseline and days 30 and 90 after discharge | 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. |
| Hemoglobin increment | Baseline and days 30 and 90 after discharge | 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 |
| Safety profile | Days 15, 30, 45 and 90 after discharge | Measured as the prevalence and severity of adverse events associated with iron treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physical function - NMS | Baseline and days 30 and 90 after discharge | 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. |
| Physical function - handgrip strength | Baseline and days 30 and 90 after discharge. | 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. |
| Physical function - 30 second sit-to-stand-test | Baseline and days 30 and 90 after discharge. | 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. |
| Fear of Falling | Days 30 and 90 after discharge | 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). |
| Cognitive impairment | Baseline and days 30 and 90 after discharge | 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. |
| Quality of life | Baseline and 90 days after discharge | 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. |
| Biochemical iron status - transferrin | Baseline and on days 30 and 90 after discharge | p-transferrin (μmol/L) measured by a venous blood sample. |
| Biochemical iron status - ferritin | Baseline and on days 30 and 90 after discharge | p-ferritin (μg/L) measured by a venous blood sample |
Countries
Denmark
Contacts
CONTACTOle Vincent Ancker, MD
CONTACTMerete Gregersen, ph.d.
Outcome results
None listed