Clinical Trial: Haemochromatosis:Phlebotomy Versus Erythrocytapheresis Therapy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Therapeutic Erythrocytapheresis as Treatment for Hemochromatosis Patients.

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: Sanquin Research & Blood Bank Divisions

Current Primary Outcome: Treatment duration and number of treatments [ Time Frame: Ferritine value 50 microgr/l ]

Original Primary Outcome:

Current Secondary Outcome: Decline in hemoglobin levels, restitution in liver functions, patient discomfort en costs [ Time Frame: Ferritine value 50microgr/l ]

Original Secondary Outcome:

Information By: Sanquin Research & Blood Bank Divisions

Dates:
Date Received: September 13, 2005
Date Started: October 2004
Date Completion:
Last Updated: October 19, 2009
Last Verified: October 2009