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Erythrocyte Apheresis Versus Phlebotomy in Hemochromatosis
This study is currently recruiting participants.
Verified by University of Bergen, July 2007
First Received: July 27, 2007   No Changes Posted
Sponsors and Collaborators: University of Bergen
Helse Fonna
Haukeland University Hospital
University Hospital, Akershus
Information provided by: University of Bergen
ClinicalTrials.gov Identifier: NCT00509652
  Purpose

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.


Condition Intervention
Hemochromatosis
Procedure: Arm 1: Erythrocyte apheresis
Procedure: Arm 2: Whole blood phlebotomy

Genetics Home Reference related topics: hemochromatosis
MedlinePlus related topics: Hemochromatosis
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: Therapeutic Effect of Erythrocyte Apheresis as Compared to Full Blood Phlebotomy in Patients With Hereditary Hemochromatosis

Further study details as provided by University of Bergen:

Primary Outcome Measures:
  • Decline in ferritin levels and transferrin saturation

Secondary Outcome Measures:
  • Decline in hemoglobin levels
  • Patient discomfort during therapeutic procedure
  • Time consumption
  • Costs

Estimated Enrollment: 67
Study Start Date: January 2006
Estimated Study Completion Date: December 2009
Arms Assigned Interventions
Arm 1: Experimental
Erythrocyte apheresis
Procedure: Arm 1: Erythrocyte apheresis
Erythrocyte apheresis
Arm 2: Active Comparator
Phlebotomy
Procedure: Arm 2: Whole blood phlebotomy
Traditional whole blood phlebotomy

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosis

    • Individuals who art homozygous for C282Y or H63D or "compound heterozygous" for these tow variants and have ferritin levels higher than 300 micrograms/L or transferrin saturation higher than 50%.
    • Individuals heterozygous for C282Y or H63D if ferritin levels higher than 500 micrograms/L or transferrin saturation higher than 50%.
  2. Requirements to the patient Body weight higher than 65 kg and initial hemoglobin level higher than 12 g/dL.

Exclusion Criteria:

  1. Contra-indications to either treatment modality
  2. Patients who are not able to co-operate
  3. Lack of informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00509652

Contacts
Contact: Tatjana Sundic, MD +47-52732000 tatjana.sundic@helse-fonna.no
Contact: Sigbjorn Berentsen, MD, PhD +47-52732000 s.beren@online.no

Locations
Norway
Haugesund Hospital, Department of Immunology and Transfusion Medicine Recruiting
Haugesund, Norway, N-5504
Contact: Tatjana Sundic, MD     +47-52732000     tatjana.sundic@helse-fonna.no    
Contact: Sigbjorn Berentsen, MD, PhD     +47-52732000     s.beren@online.no    
Haukeland University Hospital, Department of Transfusion Medicine Recruiting
Bergen, Norway, N-5021
Contact: Tor Hervig, MD, PhD     +47-55975000     tor.hervig@helse-bergen.no    
Contact: Signe Hannisdahl     +47-55975000     signe@hannisdahl@helse-bergen.no    
Akershus University Hospital (AHUS), Department of Transfusion Medicine Recruiting
Nordbyhagen, Norway, N-1474
Contact: Richard W Olaussen, MD     +47-67928800     richard.olaussen@ahus.no    
Sponsors and Collaborators
University of Bergen
Helse Fonna
Haukeland University Hospital
University Hospital, Akershus
Investigators
Principal Investigator: Tatjana Sundic, MD Department of Immunology and Transfusion Medicine, Haugesund Hospital
Study Chair: Sigbjorn Berentsen, MD, PhD Department of Medicine, Haugesund Hospital
Study Chair: Tor Hervig, MD, PhD Department of Transfusion Medicine, Haukeland University Hospital
  More Information

Additional Information:
Publications:
Study ID Numbers: NSD13903
Study First Received: July 27, 2007
Last Updated: July 27, 2007
ClinicalTrials.gov Identifier: NCT00509652     History of Changes
Health Authority: Norway: The National Committees for Research Ethics in Norway;   Norway: Norwegian Social Science Data Services

Keywords provided by University of Bergen:
Hemochromatosis
Primary hemochromatosis
Hereditary hemochromatosis
Therapy
Erythrocyte apheresis
Phlebotomy
Apheresis
Efficacy

Study placed in the following topic categories:
Metabolism, Inborn Errors
Metabolic Diseases
Genetic Diseases, Inborn
Hemochromatosis, Type 3
Hemochromatosis
Iron Metabolism Disorders
Iron Overload
Metabolic Disorder

Additional relevant MeSH terms:
Metabolism, Inborn Errors
Metabolic Diseases
Genetic Diseases, Inborn
Hemochromatosis
Iron Metabolism Disorders
Iron Overload
Metal Metabolism, Inborn Errors

ClinicalTrials.gov processed this record on May 07, 2009