Haemochromatosis:Phlebotomy Versus Erythrocytapheresis Therapy

October 19, 2009 updated by: Sanquin Research & Blood Bank Divisions

Therapeutic Erythrocytapheresis as Treatment for Hemochromatosis Patients.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Maastricht, Netherlands, 6229 GR
        • Sanquin Blood Bank Southeast Region

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Phlebotomy
Procedure: Phlebotomy
Removal of 500 ml whole blood
Other Names:
  • Bloodletting
Procedure: Erythrocytapheresis
machinal removal of erythrocytes
Other Names:
  • Therapeutic erythrocytapheresis
Active Comparator: 2
Erythrocytapheresis
Procedure: Phlebotomy
Removal of 500 ml whole blood
Other Names:
  • Bloodletting
Procedure: Erythrocytapheresis
machinal removal of erythrocytes
Other Names:
  • Therapeutic erythrocytapheresis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Treatment duration and number of treatments
Time Frame: Ferritine value 50 microgr/l
Ferritine value 50 microgr/l

Secondary Outcome Measures

Outcome Measure
Time Frame
Decline in hemoglobin levels, restitution in liver functions, patient discomfort en costs
Time Frame: Ferritine value 50microgr/l
Ferritine value 50microgr/l

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanquin Research & Blood Bank Divisions

Collaborators

Radboud University Medical Center
Maastricht University Medical Center
Atrium Medical Center

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Estimate)

October 20, 2009

Last Update Submitted That Met QC Criteria

October 19, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PPO-C- 03-006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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