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Haemochromatosis:Phlebotomy Versus Erythrocytapheresis Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00202436
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : October 20, 2009
Sponsor:
Collaborators:
Information provided by:

Study Description
Brief Summary:
In this project we plan to evaluate the effectiveness of erythrocytapheresis against phlebotomy, both regarding the impact on the reduction in iron overload as well as reduction in patient "burden". Aspects of cost effectiveness will be included in the final analysis. Results of the study would allow decision-making based on Evidence Based Medicine on the "best" therapeutic options available for newly-diagnosed as well as existing primary hemochromatosis patients.

Condition or disease Intervention/treatment Phase
Hemochromatosis Procedure: Phlebotomy Procedure: Erythrocytapheresis Phase 3

Detailed Description:
In this project we plan to evaluate the effectiveness of erythrocytapheresis against phlebotomy, both regarding the impact on the reduction in iron overload as well as reduction in patient "burden". Aspects of cost effectiveness will be included in the final analysis. The results of the study would allow decision-making based on Evidence Based Medicine on the "best" therapeutic options available for newly-diagnosed as well as existing primary hemochromatosis patients.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Therapeutic Erythrocytapheresis as Treatment for Hemochromatosis Patients.
Study Start Date : October 2004
Primary Completion Date : December 2008
Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hemochromatosis
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: 1
Phlebotomy
Procedure: Phlebotomy
Removal of 500 ml whole blood
Other Name: Bloodletting
Procedure: Erythrocytapheresis
machinal removal of erythrocytes
Other Name: Therapeutic erythrocytapheresis
Active Comparator: 2
Erythrocytapheresis
Procedure: Phlebotomy
Removal of 500 ml whole blood
Other Name: Bloodletting
Procedure: Erythrocytapheresis
machinal removal of erythrocytes
Other Name: Therapeutic erythrocytapheresis


Outcome Measures

Primary Outcome Measures :
  1. Treatment duration and number of treatments [ Time Frame: Ferritine value 50 microgr/l ]

Secondary Outcome Measures :
  1. Decline in hemoglobin levels, restitution in liver functions, patient discomfort en costs [ Time Frame: Ferritine value 50microgr/l ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hereditary haemochromatosis patients

Exclusion Criteria:

  • Malignancies, severe arrhythmias, congestive heart failure and/or recent angina, severe liver disease, epileptic seizures preceding in last 3 months before planned treatment
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00202436


Locations
Netherlands
Sanquin Blood Bank Southeast Region
Maastricht, Netherlands, 6229 GR
Sponsors and Collaborators
Sanquin Research & Blood Bank Divisions
Maastricht University Medical Center
Atrium Medical Center
Radboud University
Investigators
Principal Investigator: Eva Rombout, MD Sanquin Research and Blood Bank Divisions
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr.Wim de Kort PhD, Sanquin Blood Bank South-east
ClinicalTrials.gov Identifier: NCT00202436     History of Changes
Other Study ID Numbers: PPO-C- 03-006
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: October 20, 2009
Last Verified: October 2009

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