Haemochromatosis:Phlebotomy Versus Erythrocytapheresis Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2009-09-30

Brief Summary

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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.

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Detailed Description

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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

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Hemochromatosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

Phlebotomy

Group Type ACTIVE_COMPARATOR

Phlebotomy

Intervention Type PROCEDURE

Removal of 500 ml whole blood

Erythrocytapheresis

Intervention Type PROCEDURE

machinal removal of erythrocytes

2

Erythrocytapheresis

Group Type ACTIVE_COMPARATOR

Phlebotomy

Intervention Type PROCEDURE

Removal of 500 ml whole blood

Erythrocytapheresis

Intervention Type PROCEDURE

machinal removal of erythrocytes

Interventions

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Phlebotomy

Removal of 500 ml whole blood

Intervention Type PROCEDURE

Erythrocytapheresis

machinal removal of erythrocytes

Intervention Type PROCEDURE

Other Intervention Names

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Bloodletting Therapeutic erythrocytapheresis

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No