Clinical Management of Hereditary Hemochromatosis: Phlebotomy vs. Erythrocytoapheresis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- To prospectively determine the best choice of tretment in HH
研究概览
简要总结
The purpose of study is to determine the best and durable choice of treatment between phlebotomy and eritrocytoapheresis in the medium- and long-term clinical management of HH
详细描述
Patients affected by Hereditary hemochromatosis need a completeinitial staging of disease, a correct clinical management, a good chance of treatment and long-term follow-up. Clinical manifestations at presentation and during follow-up may consistently vary according to diagnostic criteria, treatment options and follow-up durability, up to the interruption. So, 25 caucasian patients, 16 males and 6 females of age >18 yrs. have been consecutively diagnosed and randomly included into two arms of treatment, phlebotomy vs. eritrocytoapheresis, evaluating, at baseline and 6-12-18-24-36 months, the clinical status concerning liver, kidney, pancreas, heart, endocrine iron overload and function and final outcome related to therapeutic strategy, including the cost/effectiveness analysis
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patiens newly diagnosed having Hereditary Hemochromatosis
排除标准
- •Age < 18 yrs.
- •Not obese (BMI <30)
- •Not consuming alchol beverages,
- •Not affected by systemic diseases and known hepatic viruses
结局指标
主要结局
To prospectively determine the best choice of tretment in HH
To evaluate the global outcome according to treatment choice
次要结局
- To evaluate the outcome of specific clinical features according to treatment choice