Erythrocyte Apheresis Versus Phlebotomy in Hemochromatosis

NCT00509652 | Unknown

• 1 other identifier: NSD13903
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

Hemochromatosis; Primary hemochromatosis; Hereditary hemochromatosis; Therapy; Erythrocyte apheresis; Phlebotomy; Apheresis; Efficacy

Outcome Measures

Primary Outcomes (1)

• Decline in ferritin levels and transferrin saturation

Secondary Outcomes (4)

• Decline in hemoglobin levels

• Patient discomfort during therapeutic procedure

• Time consumption

• Costs

Study Arms (2)

Arm 1

EXPERIMENTAL

Erythrocyte apheresis

Procedure: Arm 1: Erythrocyte apheresis

Arm 2

ACTIVE COMPARATOR

Phlebotomy

Procedure: Arm 2: Whole blood phlebotomy

Interventions

Arm 1: Erythrocyte apheresis PROCEDURE

Erythrocyte apheresis

Arm 1

Arm 2: Whole blood phlebotomy PROCEDURE

Traditional whole blood phlebotomy

Arm 2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Contra-indications to either treatment modality
• Patients who are not able to co-operate
• Lack of informed consent

Sponsors & Collaborators

• University of Bergen: lead
• Helse Fonna: collaborator
• Haukeland University Hospital: collaborator
• University Hospital, Akershus: collaborator

Study Sites (3)

Haukeland University Hospital, Department of Transfusion Medicine

Bergen, N-5021, Norway

RECRUITING

Haugesund Hospital, Department of Immunology and Transfusion Medicine

Haugesund, N-5504, Norway

RECRUITING

Akershus University Hospital (AHUS), Department of Transfusion Medicine

Nordbyhagen, N-1474, Norway

RECRUITING

Related Publications (5)

• Asberg A, Hveem K, Thorstensen K, Ellekjter E, Kannelonning K, Fjosne U, Halvorsen TB, Smethurst HB, Sagen E, Bjerve KS. Screening for hemochromatosis: high prevalence and low morbidity in an unselected population of 65,238 persons. Scand J Gastroenterol. 2001 Oct;36(10):1108-15. doi: 10.1080/003655201750422747.

  PMID: 11589387 BACKGROUND

• Muncunill J, Vaquer P, Galmes A, Obrador A, Parera M, Bargay J, Besalduch J. In hereditary hemochromatosis, red cell apheresis removes excess iron twice as fast as manual whole blood phlebotomy. J Clin Apher. 2002;17(2):88-92. doi: 10.1002/jca.10024.

  PMID: 12210712 BACKGROUND

• Rombout-Sestrienkova E, van Noord PA, van Deursen CT, Sybesma BJ, Nillesen-Meertens AE, Koek GH. Therapeutic erythrocytapheresis versus phlebotomy in the initial treatment of hereditary hemochromatosis - A pilot study. Transfus Apher Sci. 2007 Jun;36(3):261-7. doi: 10.1016/j.transci.2007.03.005. Epub 2007 Jun 13.

  PMID: 17569592 BACKGROUND

• Knutsen, H. & Hammerstrom, J. Handlingsprogram for hemokromatose [Norwegian national program for treatment of haemochromatosis]. http://www.legeforeningen.no/asset/22333/1/22333_1.doc . 2003. Norwegian Society of Haematology.

  BACKGROUND

• Telset BIV. Behandling av hereditær hemokromatose: fullblodstapping eller erytrocyttaferese? [Treatment of hereditary haemochromatosis: whole blood phlebotomy or red cell apheresis?] Master Thesis. Bergen: Faculty of Medicine, University of Bergen, 2004

  BACKGROUND

MeSH Terms

Conditions

Hemochromatosis

Condition Hierarchy (Ancestors)

Metal Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Iron Overload; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Tatjana Sundic, MD

  Department of Immunology and Transfusion Medicine, Haugesund Hospital

  PRINCIPAL INVESTIGATOR

• Sigbjorn Berentsen, MD, PhD

  Department of Medicine, Haugesund Hospital

  STUDY CHAIR

• Tor Hervig, MD, PhD

  Department of Transfusion Medicine, Haukeland University Hospital

  STUDY CHAIR

Central Study Contacts

Tatjana Sundic, MD

CONTACT

+47-52732000; tatjana.sundic@helse-fonna.no

Sigbjorn Berentsen, MD, PhD

CONTACT

+47-52732000; s.beren@online.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 27, 2007
• First Posted: July 31, 2007
• Study Start: January 1, 2006
• Study Completion: December 1, 2009
• Last Updated: July 31, 2007

Record last verified: 2007-07

Locations

NO (3)