NL-OMON50596已完成不适用
The transferrin saturation/hepcidin radio: a study on the diagnostic value in the differentiation of Iron Refractory Iron Deficiency Anemia from Iron Deficiency Anemia - SATURNUS study
Maxima Medisch Centrum0 个研究点目标入组 94 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 94
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Inclusion of subjects in the IRIDA group will take place from a population
- •earlier studied by Donker et al, for these subjects clinical data are already
- •available. (Donker et al, Am J Hematol 2016), Inclusion of subjects in the
- •non-IRIDA, iron deficiency anemia group will take place at the gynaecological
- •department (women suffering from menorrhagia) and at the gastrointestinal
- •department (gastrointestinal blood loss and/or malabsorption), the cardiology
- •department, the ER of the Maxima Medical Center
- •IRIDA group
- •In order to be included in this study an IRIDA patient should meet the
- •following criteria:
- •- Previous diagnosis as a mono-allelic or bi-allelic IRIDA patient with an
- •IRIDA phenotype detected after clinical presentation
- •- Presence of microcytic anemia (MCV < 80 fL and Hb <7.5 mmol/L for women, Hb <
- •8.5 mmol/L for men)
- •- Transferrin saturation (TSAT) < 10%
- •- Absence of inflammation (CRP < 10 mg/L)
- •- Not or partially responsive to oral iron (responsiveness to oral iron defined
- •as Hb increment of 2 g/dL after 3 weeks of iron therapy)
- •- Age above 18 years
- •-TSAT/hepcidin ratio available, determined in the absence of inflammation,
- •Based on these criteria 4 patients in a population of 21 will be excluded
- •because either the patient was < 18 years or the TSAT/hepcidin ratio was not
- •available, or not available in the absence of inflammation.
- •The other 17 IRIDA patients will be included in the study; 11 IRIDA patients in
- •the bi-allelic affected group, with a homozygous or a compound heterozygous
- •TMPRSS6 defect, and 6 subjects in the mono-allelic affected group with a
- •heterozygous TMPRSS6 defect., Control group, Because the controls in the
- •SATURNUS study all have a microcytic anemia comparable with the IRIDA group,
- •the phenotype is not discriminative. Therefore, in all controls genotyping of
- •the exons of TMPRSS6 will be performed. A relevant phenotype, see below, in
- •combination with the absence of pathological TMPRSS6 variants on both alleles
- •will be defined as non-IRIDA and will be eligible as control. , Inclusion of
- •subjects in the control group will take place at the above mentioned
- •departments of the Máxima Medical Centrum Veldhoven and Radboudumc Nijmegen.
- •In order to be eligible to participate in this study a subject should meet the
- •following criteria:
- •o Presence of microcytic anemia (MCV <80 fL and Hb <7.5 mmol/L L for women, Hb
- •< 8.5 mmol/L for men)
- •o Ferritin <40 µg/L
- •o Age >18 years
- •o Low TSAT (TSAT <10%)
- •o Absence of inflammation (CRP < 10 mg/L)
- •o Absence of pathological TMPRSS6 variants in exons of both alleles, - After
- •counselling of a potential eligible patient by the Emergency Room doctor, the
- •cardiologist, the gastro-intestinal specialist or the gynaecologist, blood is
- •withdrawn for the determination of Hb, MCV, ferritin and CRP level. Extra blood
- •is withdrawn and stored for the determination of hepcidin and for DNA studies
- •on TMPRSS6 defects in case the subject had indeed an iron deficiency anemia
- •without inflammation and has given informed consent. In case the subject does
- •not meet the inclusion criteria or does not give informed consent, this extra
- 另有 1 项未显示
排除标准
- •IRIDA group: see above, D4a, inclusions already done, Control group
- •Subjects with the following criteria will not be able to participate in the
- •study because these criteria interfere with the TSAT and hepcidin values.
- •- Pregnancy
- •- Oral iron supplements in the last 3 months before referral to the
- •gynaecologist or gastrointestinal specialist
- •- Diagnosis with any disease associated with inflammation including
- •malignancies, chronic liver and kidney diseases
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