Haemochromatosis:Phlebotomy Versus Erythrocytapheresis Therapy - Full Text View

Sponsor:	Sanquin Research & Blood Bank Divisions
Collaborators:	Maastricht University Medical Center Atrium Medical Center Radboud University
Information provided by:	Sanquin Research & Blood Bank Divisions
ClinicalTrials.gov Identifier:	NCT00202436

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. 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
Hemochromatosis	Procedure: Phlebotomy Procedure: Erythrocytapheresis	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Therapeutic Erythrocytapheresis as Treatment for Hemochromatosis Patients.

Resource links provided by NLM:

Genetics Home Reference related topics: hemochromatosis

MedlinePlus related topics: Hemochromatosis

U.S. FDA Resources

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

Primary Outcome Measures:

Treatment duration and number of treatments [ Time Frame: Ferritine value 50 microgr/l ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Decline in hemoglobin levels, restitution in liver functions, patient discomfort en costs [ Time Frame: Ferritine value 50microgr/l ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	October 2004
Study Completion Date:	September 2009
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

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
Study First Received:	September 13, 2005
Last Updated:	October 19, 2009
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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 February 12, 2012