Hemochromatosis:Phlebotomy Versus Erythrocytapheresis Therapy

This study is currently recruiting patients. Verified by Sanquin Research & Blood Bank Divisions September 2005

Purpose

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.

Condition	Intervention	Phase
Haemochromatosis	Procedure: Phlebotomy, erythrocytapheresis	Phase III

MedlinePlus related topics: Hemochromatosis
Genetics Home Reference related topics: hemochromatosis

Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Official Title: Therapeutic Erythrocytapheresis as Treatment for Hemochromatosis Patients.

Further study details as provided by Sanquin Research & Blood Bank Divisions:

Expected Total Enrollment: 40

Study start: October 2004

Eligibility

Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both

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

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier NCT00202436

Eva Rombout 0031433871456 e.rombot@sanquin.nl

Netherlands
Sanquin Blood Bank Southeast Region, Maastricht, 6229 GR, Netherlands; Recruiting

Eva Rombout, MD e.rombout@sanquin.nl
Eva Rombout, MD, Principal Investigator

Study chairs or principal investigators

Eva Rombout, MD, Principal Investigator, Sanquin Research and Blood Bank Divisions

More Information

http://www.sanquinresearch.nl

Study ID Numbers: PPO-C- 03-006
Last Updated: June 7, 2006
Record first received: September 13, 2005
ClinicalTrials.gov Identifier: NCT00202436
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
ClinicalTrials.gov processed this record on 2006-10-10

U.S. National Library of Medicine, Contact NLM Customer Service
National Institutes of Health, Department of Health & Human Services
Copyright

Resources

Dr Whittingtons Book

Free Articles on Hemochromatosis

CDC Hemochromatosis Brochure

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