Haemochromatosis:Phlebotomy Versus Erythrocytapheresis Therapy

Phase 3

Completed

• Conditions: Hemochromatosis
• Interventions: Procedure: Phlebotomy; Procedure: Erythrocytapheresis

• Registration Number: NCT00202436
• Lead Sponsor: Sanquin Research & Blood Bank Divisions

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 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.

Study Timeline

• Study Start: 2004-10
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-20
• Primary Completion: 2008-12
• Study Completion: 2009-09
• Status Verified: 2009-10
• Last Update Submitted: 2009-10-19
• Last Update Posted: 2009-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Phlebotomy	Phlebotomy
1	Erythrocytapheresis	Phlebotomy
2	Phlebotomy	Erythrocytapheresis
2	Erythrocytapheresis	Erythrocytapheresis

Primary Outcome Measures

Name	Time	Method
Treatment duration and number of treatments	Ferritine value 50 microgr/l

Secondary Outcome Measures

Name	Time	Method
Decline in hemoglobin levels, restitution in liver functions, patient discomfort en costs	Ferritine value 50microgr/l

Trial Locations

Locations (1)

Sanquin Blood Bank Southeast Region; 🇳🇱 Maastricht, Netherlands