Haemochromatosis:Phlebotomy Versus Erythrocytapheresis Therapy

Therapeutic Erythrocytapheresis as Treatment for Hemochromatosis Patients.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00202436

Enrollment

Registered

2005-09-20

Start date

2004-10-31

Completion date

2009-09-30

Last updated

2009-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemochromatosis

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.

Interventions

PROCEDUREPhlebotomy

Removal of 500 ml whole blood

PROCEDUREErythrocytapheresis

machinal removal of erythrocytes

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Treatment duration and number of treatments	Ferritine value 50 microgr/l

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 16, 2026