Trial record 1 of 38 for:    hemochromatosis
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Erythrocyte Apheresis Versus Phlebotomy in Hemochromatosis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2007 by University of Bergen.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Helse Fonna
Haukeland University Hospital
University Hospital, Akershus
Information provided by:
University of Bergen
ClinicalTrials.gov Identifier:
NCT00509652
First received: July 27, 2007
Last updated: NA
Last verified: July 2007
History: No changes posted
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Therapeutic Effect of Erythrocyte Apheresis as Compared to Full Blood Phlebotomy in Patients With Hereditary Hemochromatosis

Resource links provided by NLM:


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
Experimental: Arm 1
Erythrocyte apheresis
Procedure: Arm 1: Erythrocyte apheresis
Erythrocyte apheresis
Active Comparator: Arm 2
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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   
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   
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

Publications:
ClinicalTrials.gov Identifier: NCT00509652     History of Changes
Other Study ID Numbers: NSD13903
Study First Received: July 27, 2007
Last Updated: July 27, 2007
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Norwegian Social Science Data Services

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

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

ClinicalTrials.gov processed this record on July 31, 2014