Haemochromatosis:Phlebotomy Versus Erythrocytapheresis Therapy
Therapeutic Erythrocytapheresis as Treatment for Hemochromatosis Patients.
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Oct 2004
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 20, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2009
CompletedOctober 20, 2009
October 1, 2009
4.2 years
September 13, 2005
October 19, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
Treatment duration and number of treatments
Ferritine value 50 microgr/l
Secondary Outcomes (1)
Decline in hemoglobin levels, restitution in liver functions, patient discomfort en costs
Ferritine value 50microgr/l
Study Arms (2)
1
ACTIVE COMPARATORPhlebotomy
2
ACTIVE COMPARATORErythrocytapheresis
Interventions
machinal removal of erythrocytes
Eligibility Criteria
You may qualify if:
- Hereditary haemochromatosis patients
You may not qualify if:
- Malignancies, severe arrhythmias, congestive heart failure and/or recent angina, severe liver disease, epileptic seizures preceding in last 3 months before planned treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanquin Research & Blood Bank Divisionslead
- Maastricht University Medical Centercollaborator
- Atrium Medical Centercollaborator
- Radboud University Medical Centercollaborator
Study Sites (1)
Sanquin Blood Bank Southeast Region
Maastricht, 6229 GR, Netherlands
Related Publications (2)
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.
PMID: 33368569DERIVEDRombout-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.
PMID: 21848963DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eva Rombout, MD
Sanquin Research and Blood Bank Divisions
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 20, 2005
Study Start
October 1, 2004
Primary Completion
December 1, 2008
Study Completion
September 1, 2009
Last Updated
October 20, 2009
Record last verified: 2009-10