Erythrocyte Apheresis Versus Phlebotomy in Hemochromatosis
Recruitment status was Recruiting
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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 |
- Decline in ferritin levels and transferrin saturation
- 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
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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%.
- Requirements to the patient Body weight higher than 65 kg and initial hemoglobin level higher than 12 g/dL.
Exclusion Criteria:
- Contra-indications to either treatment modality
- Patients who are not able to co-operate
- Lack of informed consent
Contact: Tatjana Sundic, MD | +47-52732000 | tatjana.sundic@helse-fonna.no |
Contact: Sigbjorn Berentsen, MD, PhD | +47-52732000 | s.beren@online.no |
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 |
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 |
Additional 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 October 17, 2012