The Effects of Intravenous Iron on Mobility in Elderly Patients Following Hip Fracture Surgery: a Multicentre, Parallel Group, Randomised Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 210
- 试验地点
- 6
- 主要终点
- New Mobility Score (NMS)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Participant: Blinded Primary Investigators: Blinded Coordinating Investigator: Blinded Project Manager: Blinded Database Manager: Not Blinded Obtaining baseline values (dedicated staff): Blinded Department Health Care Prof. (giving intervention): Not blinded Outcome Assessor (dedicated staff): Blinded IronHip steering committee: Blinded Sponsor: Blinded Statistician: Blinded
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Placebo
干预措施: Saline (NaCl 0,9 %) (placebo) (Drug)
Active Investigational Medicinal Product
干预措施: Ferric Derisomaltose (Drug)
结局指标
主要结局
New Mobility Score (NMS)
时间窗: Measured as the change from baseline (reported as pre-fracture NMS) in the New Mobility Score after 4, 6 and 12 weeks
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.
次要结局
- Serious adverse event (SAE)(Will be assessed up to the 6 weeks follow up)
- Hemoglobin(Measured at baseline, 6 and 12 weeks after intervention.)
- Red blood cell transfusion requirement(Measured on postoperative day (POD) 7 and POD 30)
- Fatigue, assessed using the Verbal Rating Scale for Fatigue (F-VRS)(Measured at baseline, 4, 6 and 12 weeks after intervention.)
- Quality of life with EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L )(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)(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)(Measured at baseline and at 6 and 12 weeks after intervention.)
- 30 second Sit-to-Stand-Test (STS)(Measured at baseline, 6 and 12 weeks)
- Activity of daily living, asessed with Barthel Index 20(Measured as a retrograde baseline and at 6 and 12 weeks after intervention)
- Pain, assessed using the Verbal Rating Scale for pain(Measured at baseline and at 6 and 12 weeks after intervention)
- Days alive and at home up to 30 (DAH30)(Measured at 6 weeks after intervention.)
- Mortality(90 days)
研究者
Soren Overgaard
Clinical Professor, DMSc
University Hospital Bispebjerg and Frederiksberg