跳至主要内容
临床试验/NCT01331603
NCT01331603Unknown不适用

Assessment of Labile Plasma Iron (LPI) as an Alternative Parameter for Iron Overload in MDS and Primary Myelofibrosis Patients With Iron Overload and Its Correlations With the Classical Iron Overload Parameters.

Wolfson Medical Center1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2011年3月最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
试验地点
1
主要终点
The value of Ferritin,Transferrin Saturation,CRP and LPI at the blood samples

研究概览

简要总结

Recently, it has been demonstrated that iron overload is associated with the appearance of labile plasma iron (LPI).

LPI is redox active and is rapidly taken up by cells, leading to a rise in the labile iron pool (LIP) and catalyzing generation of reactive oxygen species (ROS), which can lead to cellular damage.

The LPI data are mostly derived from thalassemia iron overload research , however, there are a few data describing LPI and its correlations with the classical iron overload parameters (ferritin, TSAT) in acute anemias such as MDS Therefore we are going to assess LPI in iron overloaded myelodysplastic syndromes (MDS) (low and high risk) and primary myelofibrosis, in order to assess whether it can be used as alternative to the routinely used parameters; TSAT and ferritin levels.

详细描述

Approximately 60-80% of patients with myelodysplastic syndromes (MDS) present with symptomatic anemia and 80-90%, of these, will require red blood cell (RBC) transfusions. Excess transfusional iron causes iron overload (IO) which is characterized by elevated serum ferritin (> 1000ng/ml) and transferrin saturation (TSAT > 50%) levels.

Assessment of IO using serum ferritin and TSAT levels is not accurate enough and this is due to changes in serum ferritin and TSAT during any inflammatory condition.

Since serum ferritin is considered as a positive acute phase reactant and therefore inflammatory state can lead to an increase in serum ferritin levels and so does not reflect the exact amount of iron overload.

In contrast TSAT can decrease during inflammation and in addition it follows diurnal variations.The aim of our present study is to asses the levels of LPI in patients with in iron overloaded MDS patients (low and high risk), and also patients with primary myelofibrosis, in order to find out any laboratory correlations between LPI, TSAT and srum ferritin levels.

Methods:

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age > 18 years old
  • MDS patients (low and high risk )

排除标准

  • age < 18 years old

结局指标

主要结局

The value of Ferritin,Transferrin Saturation,CRP and LPI at the blood samples

时间窗: 1 year

The blood samples should be taken at least one week apart from last blood transfusion. In case of infection or acute inflammation , blood samples should be taken only one week after resolution of these conditions.

次要结局

未报告次要终点

研究者

申办方类型
Other Gov

研究点 (1)

Loading locations...

相似试验