Back to resultsHaemochromatosis:Phlebotomy Versus Erythrocytapheresis Therapy
Primary Purpose
Hemochromatosis
Status
Completed
Phase
Phase 3
Locations
Netherlands
Study Type
Interventional
Intervention
Phlebotomy
Erythrocytapheresis
Sponsored by
About this trial
This is an interventional treatment trial for Hemochromatosis
Eligibility 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
Sites / Locations
- Sanquin Blood Bank Southeast Region
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
Phlebotomy
Erythrocytapheresis
Outcomes
Primary Outcome Measures
Treatment duration and number of treatments
Secondary Outcome Measures
Decline in hemoglobin levels, restitution in liver functions, patient discomfort en costs
Full Information
NCT ID
NCT00202436
First Posted
September 13, 2005
Last Updated
October 19, 2009
Sponsor
Sanquin Research & Blood Bank Divisions
Collaborators
Maastricht University Medical Center, Atrium Medical Center, Radboud University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00202436
Brief Title
Haemochromatosis:Phlebotomy Versus Erythrocytapheresis Therapy
Official Title
Therapeutic Erythrocytapheresis as Treatment for Hemochromatosis Patients.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sanquin Research & Blood Bank Divisions
Collaborators
Maastricht University Medical Center, Atrium Medical Center, Radboud University Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemochromatosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Phlebotomy
Arm Title
2
Arm Type
Active Comparator
Arm Description
Erythrocytapheresis
Intervention Type
Procedure
Intervention Name(s)
Phlebotomy
Other Intervention Name(s)
Bloodletting
Intervention Description
Removal of 500 ml whole blood
Intervention Type
Procedure
Intervention Name(s)
Erythrocytapheresis
Other Intervention Name(s)
Therapeutic erythrocytapheresis
Intervention Description
machinal removal of erythrocytes
Primary Outcome Measure Information:
Title
Treatment duration and number of treatments
Time Frame
Ferritine value 50 microgr/l
Secondary Outcome Measure Information:
Title
Decline in hemoglobin levels, restitution in liver functions, patient discomfort en costs
Time Frame
Ferritine value 50microgr/l
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eva Rombout, MD
Organizational Affiliation
Sanquin Research and Blood Bank Divisions
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sanquin Blood Bank Southeast Region
City
Maastricht
ZIP/Postal Code
6229 GR
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
33368569
Citation
Rombout-Sestrienkova E, Winkens B, van Kraaij M, van Deursen CTBM, Janssen MCH, Rennings AMJ, Evers D, Kerkhoffs JL, Masclee A, Koek GH. A predictive model for estimating the number of erythrocytapheresis or phlebotomy treatments for patients with naive hereditary hemochromatosis. J Clin Apher. 2021 Jun;36(3):340-347. doi: 10.1002/jca.21867. Epub 2020 Dec 24.
Results Reference
derived
PubMed Identifier
21848963
Citation
Rombout-Sestrienkova E, Nieman FH, Essers BA, van Noord PA, Janssen MC, van Deursen CT, Bos LP, Rombout F, van den Braak R, de Leeuw PW, Koek GH. Erythrocytapheresis versus phlebotomy in the initial treatment of HFE hemochromatosis patients: results from a randomized trial. Transfusion. 2012 Mar;52(3):470-7. doi: 10.1111/j.1537-2995.2011.03292.x. Epub 2011 Aug 16.
Results Reference
derived
Learn more about this trial
Haemochromatosis:Phlebotomy Versus Erythrocytapheresis Therapy
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