Intravenous Ferric Carboxymaltose (Ferinject®) With or Without Erythropoietin for the Correction of Preoperative Anaemia in Patients Undergoing Orthopaedic Surgery
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Hb increase from baseline till day of surgery
研究概览
简要总结
Study Design: Single-centre, block randomised, blinded, controlled, phase IIIb, parallel group pilot study.
Primary Objective:
• To evaluate the effect of the administration of ferric carboxymaltose (Ferinject®) with or without erythropoietin vs. no treatment (standard therapy) on the preoperative anaemia status in patients undergoing orthopaedic surgery
Secondary Objective:
- To gain informations for the design of a possible follow-up study
- To evaluate the effect of the administration of ferric carboxymaltose (Ferinject®) with or without erythropoietin vs. no treatment (standard therapy) on pre- and postoperative Hb levels, iron status, transfusion rate, days until discharge.
- To evaluate the tolerability and safety of Ferinject®
Study Centres:
This is a single centre study
Patients:
A total of 75 completed patients (50 patients in the intravenous iron treatment groups and 25 patients in the no treatment group will be recruited.
详细描述
TREATMENT:
Patients will be randomised 1:1:1 to one of the following groups:
Group I - Ferinject ® and EPO treatment group 25 patients will be randomised to the Ferinject and EPO treatment group.
For each patient, the cumulative total iron requirement will be calculated using the formula of Ganzoni [Ganzoni et al, 1970]:
Iron deficit [mg] = b.w. [kg]† x (target Hb - actual Hb) [g/L] x 0.24†† + depot iron [mg]
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •> 18 years of age and signed written informed consent
- •Patients scheduled to undergo major orthopaedic surgery (hip or knee arthroplasty or back surgery)
- •10 g/dl < Hb < 13.0 g/dl for men and 10 g/dl < Hb < 12.0 g/dl for women, at screening ( 3 weeks prior to surgery)
- •Ferritin < 100 μg/l or 100-300 with TSat < 20%
排除标准
- •Suspicion of iron overload (Ferritin >300 μg/l or/and TSAT>50%)
- •Active severe infection/inflammation (defined as serum CRP > 20 mg/l) or diagnosed malignancy
- •Folate-and/or Vitamin B12 deficiency (according to local lab reference range)
- •Known history of hepatitis B/C or HIV-positive
- •Liver values 3 times higher than normal
- •Immunosuppressive or myelosuppressive therapy
- •A concurrent medical condition(s) that, in the view of the investigator, would prevent compliance or participation or jeopardize the health of the patients.
- •Pregnancy or lactation
- •Transfusion within 1 month prior to study inclusion, EPO treatment with in the last 4 weeks, any iron treatment within 4 weeks prior to the inclusion in the trail
- •Participation in any other therapeutic trial within the previous month
- •History of thromboembolic events in the family or the patient
- •Severe peripheral, coronary or carotid artery disease
- •Bodyweight < 50 kg
- •Patients not able to understand the German language
研究组 & 干预措施
1
Placebo for EPO and for Ferinject ®
干预措施: Ferinject ® (Drug)
2
Only Ferinject ® , Placebo for EPO
干预措施: Ferinject ® (Drug)
3
Ferinject ® + EPO
干预措施: Ferinject ® (Drug)
结局指标
主要结局
Hb increase from baseline till day of surgery
时间窗: 6 weeks
次要结局
未报告次要终点