Hereditary Hemochromatosis
Conditions
Keywords
Clinical Management, Phlebotomy, Eritrocytoapheresis
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
Interventions
PROCEDUREEritrocytoapheresis
Sponsors
San Filippo Neri General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Patiens newly diagnosed having Hereditary Hemochromatosis
Exclusion criteria
* Age \< 18 yrs. * Not obese (BMI \<30) * Not consuming alchol beverages, * Not affected by systemic diseases and known hepatic viruses
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To prospectively determine the best choice of tretment in HH | — |
| To evaluate the global outcome according to treatment choice | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the outcome of specific clinical features according to treatment choice | — |
Countries
Italy
Outcome results
None listed