Clinical Management of Hereditary Hemochromatosis: Phlebotomy vs. Erythrocytoapheresis
- Conditions
- Hereditary Hemochromatosis
- Registration Number
- NCT00440986
- Lead Sponsor
- San Filippo Neri General Hospital
- Brief Summary
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
- Detailed Description
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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
- Patiens newly diagnosed having Hereditary Hemochromatosis
- Age < 18 yrs.
- Not obese (BMI <30)
- Not consuming alchol beverages,
- Not affected by systemic diseases and known hepatic viruses
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method To prospectively determine the best choice of tretment in HH To evaluate the global outcome according to treatment choice
- Secondary Outcome Measures
Name Time Method To evaluate the outcome of specific clinical features according to treatment choice
Trial Locations
- Locations (1)
Department of Transfusion Medicine-San Filippo Neri General Hospital
🇮🇹Rome, Italy