Haemochromatosis:Phlebotomy Versus Erythrocytapheresis Therapy

Sanquin Research & Blood Bank Divisions

Status and phase

Completed

Phase 3

Conditions

Hemochromatosis

Treatments

Procedure: Erythrocytapheresis

Procedure: Phlebotomy

Study type

Interventional

Funder types

Other

Identifiers

NCT00202436

PPO-C- 03-006

Details and patient eligibility

About

In this project we plan to evaluate the effectiveness of erythrocytapheresis against phlebotomy, both regarding the impact on the reduction in iron overload as well as reduction in patient "burden". Aspects of cost effectiveness will be included in the final analysis. Results of the study would allow decision-making based on Evidence Based Medicine on the "best" therapeutic options available for newly-diagnosed as well as existing primary hemochromatosis patients.

Full description

In this project we plan to evaluate the effectiveness of erythrocytapheresis against phlebotomy, both regarding the impact on the reduction in iron overload as well as reduction in patient "burden". Aspects of cost effectiveness will be included in the final analysis. The results of the study would allow decision-making based on Evidence Based Medicine on the "best" therapeutic options available for newly-diagnosed as well as existing primary hemochromatosis patients.

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Hereditary haemochromatosis patients

Exclusion criteria

Malignancies, severe arrhythmias, congestive heart failure and/or recent angina, severe liver disease, epileptic seizures preceding in last 3 months before planned treatment