NCT00202436

Haemochromatosis:Phlebotomy Versus Erythrocytapheresis Therapy

Therapeutic Erythrocytapheresis as Treatment for Hemochromatosis Patients.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Sanquin Research & Blood Bank Divisions · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Hemochromatosis

Interventions

Type	Name	Description
PROCEDURE	Phlebotomy	Removal of 500 ml whole blood
PROCEDURE	Erythrocytapheresis	machinal removal of erythrocytes

Timeline

• Start date: 2004-10-01
• Primary completion: 2008-12-01
• Completion: 2009-09-01
• First posted: 2005-09-20
• Last updated: 2009-10-20

Locations

1 site across 1 country: Netherlands