Erythrocyte Apheresis Versus Phlebotomy in Hemochromatosis

Summary

Primary hemochromatosis is the most frequent hereditary condition in Scandinavia. The condition may result in serious organ damage which can be prevented by therapy, but only few patients develop such organ damage. The optimal treatment, therefore, is still a matter of discussion Prevention of organ damage has traditionally been accomplished by drawing of full blood (phlebotomy), which has to be frequently repeated during the initial phase and then continued indefinitely as a maintenance treatment. The removed amount of iron may be increased two- or threefold for each procedure by using modern equipment for selective removal of red blood cells (red cell apheresis). Possible drawbacks of this technique may be higher costs, prolonged time for each therapeutic procedure, and certain requirements to the patients. The possible advantages are the reduced number of therapeutic procedures and less strain for the patient. No larger, randomized study has been published in order to determine which method should be preferred.

This study is a controlled trial in which participating patients are asked to be randomized to red cell apheresis or traditional phlebotomy. Each group will be followed by means of well-defined assessments in order to explore possible advantages and disadvantages of each method in order to establish what type of treatment should be recommended.

Conditions

• Hemochromatosis

Interventions

PROCEDURE

Arm 1: Erythrocyte apheresis

Erythrocyte apheresis

PROCEDURE

Arm 2: Whole blood phlebotomy

Traditional whole blood phlebotomy

Sponsors & Collaborators

• Helse Fonna

  collaborator OTHER

• Haukeland University Hospital

  collaborator OTHER

• University Hospital, Akershus

  collaborator OTHER

• University of Bergen

  lead OTHER

Principal Investigators

• Tatjana Sundic, MD · Department of Immunology and Transfusion Medicine, Haugesund Hospital

• Sigbjorn Berentsen, MD, PhD · Department of Medicine, Haugesund Hospital

• Tor Hervig, MD, PhD · Department of Transfusion Medicine, Haukeland University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2006-01-31

Completion

2009-12-31

Countries

• Norway

Study Locations