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Completed

NCT Number: NCT00202436

Haemochromatosis:Phlebotomy Versus Erythrocytapheresis Therapy

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sanquin Blood Bank Southeast Region

Maastricht, 6229 GR, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Phlebotomy

Procedure

Removal of 500 ml whole blood

Other names: Bloodletting

Erythrocytapheresis

Procedure

machinal removal of erythrocytes

Other names: Therapeutic erythrocytapheresis

Primary outcomes

  1. Treatment duration and number of treatments

    Time frame: Ferritine value 50 microgr/l

Secondary outcomes

  1. Decline in hemoglobin levels, restitution in liver functions, patient discomfort en costs

    Time frame: Ferritine value 50microgr/l

Sponsors and collaborators

Lead sponsor

Sanquin Research & Blood Bank Divisions

Other

Collaborators

  • Atrium Medical Center
  • Maastricht University Medical Center
  • Radboud University Medical Center

Registry information

Official study title

Therapeutic Erythrocytapheresis as Treatment for Hemochromatosis Patients.

Important dates

Study start
2004
Primary completion
2008
Study completion
2009
First posted
Sep 20, 2005
Registry last updated
Oct 20, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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