EUCTR2017-003439-12-AT进行中（未招募）1 期
Safety and efficacy of postoperative i.v. iron substitution with Polyglucoferron compared to Ferric Carboxymaltose and oral iron in patients with diagnosed iron deficiency anaemia pre- orpostoperatively (IDA II)
Fraunhofer Gesellschaft für sein Institut für Translationale Medizin und Pharmakologie (ITMP)0 个研究点目标入组 407 人开始时间: 2019年4月25日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 407
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Male or female; aged = 18 years
- •Patients with planned surgery (e.g., orthopaedic/trauma, vascular,
- •visceral, cardiac surgery)
- •Confirmed and documented preoperative (within 28 days before
- •surgery) iron deficiency defined as S-ferritin <100 ng/mL
- •Confirmed and documented anaemia (Hb <12 g/dL for female and
- •<13 g/dL for male) up to 10 days before surgery or until 72 h after
- •start of surgery
- •Confirmed anaemia at Baseline (Hb <12 g/dL for female and <13 g/dL
- •Written informed consent; willing / able to comply with the protocol
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 204
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 203
排除标准
- •Pregnancy in female patients or breastfeeding women
- •Female patients not willing to use a safe method of contraception (PEARL index <1) for the full study period
- •Severe physical inability, e.g., ASA physical status IV or V
- •Patients receiving blood transfusion 24 week prior surgery
- •Patients with severe anaemia defined as Hb = 8 g/dL or with moderate
- •anaemia with evidence of risk factors or signs of cardiac or cerebral
- •ischaemia defined as clinical need for allogenic red blood cell
- •transfusion (see section 4.4)
- •Non-iron deficiency anaemia, e.g., known Vitamin B12 or folate deficiency, haemoglobinopathy, or unexplained anaemia
- •Anticipated medical need for erythropoesis-stimulating agents during the main study period
- •Patients with hemodynamic instability due to any ongoing bleeding. Absence of ongoing bleeding will be confirmed either by decision of two independent physicians or by removal of drainage, whichever occurs earlier in routine care
- •Patients with any contraindication to the investigational products, e.g.,
- •o known sensitivity to iron or an ingredient of the investigational products
- •o Significant history of systemic allergic reactions
- •o Haemachromatosis, thalassemia or TSAT >50% as indicator of iron overload
- •o Acute or chronic intoxication
- •o Infection (patient on non-prophylactic antibiotics)
- •o Chronic liver disease and/or screening ALT or AST above three times the upper limit of the normal range
- •Chronic kidney disease, defined as GFR <30 mL/min
- •Immune-mediated diseases such as rheumatoid arthritis or inflammatory bowel disease if active and uncontrolled
- •Primary haematologic disease
- •Drug or alcohol abuse according to WHO definition
- •Potentially unreliable patients, and those judged by the investigator to be unsuitable for the study
- •Current or previous participation in another clinical trial during the last 90 days before screening
- •Exclusion criteria related to Ferrous sulfate:
- •according to SmPC
- •hypersensitivity to any ingredient in the formulation
- •concomitant parenteral iron
- •haemochromatosis, and other iron overload syndromes
- •Exclusion criteria related to Ferric Carboxymaltose:
- •according to SmPC
- •hypersensitivity to the active substance, to Ferric Carboxymaltose or any of its excipients
- •known serious hypersensitivity to other parenteral iron products
- •anaemia not attributed to iron deficiency
- •evidence of iron overload or disturbances in the utilisation of iron
- •Exclusion criteria related to Polyglucoferron:
- •hypersensitivity to any ingredient in the formulation
- •known serious hypersensitivity to other parenteral iron products
- •anaemia not attributed to iron deficiency
- •evidence of iron overload or disturbances in the utilisation of iron
研究者
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