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Haemochromatosis:Phlebotomy Versus Erythrocytapheresis Therapy

NCT00202436 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2009-10-20

No results posted yet for this study

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.

Conditions

  • Hemochromatosis

Interventions

PROCEDURE

Phlebotomy

Removal of 500 ml whole blood

PROCEDURE

Erythrocytapheresis

machinal removal of erythrocytes

Sponsors & Collaborators

  • Maastricht University Medical Center

    collaborator OTHER

  • Atrium Medical Center

    collaborator OTHER

  • Radboud University Medical Center

    collaborator OTHER

  • Sanquin Research & Blood Bank Divisions

    lead OTHER

Principal Investigators

  • Eva Rombout, MD · Sanquin Research and Blood Bank Divisions

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-10-31
Primary Completion
2008-12-31
Completion
2009-09-30

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00202436 on ClinicalTrials.gov