Haemochromatosis:Phlebotomy Versus Erythrocytapheresis Therapy
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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 3 |
| 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. |
- Treatment duration and number of treatments [ Time Frame: Ferritine value 50 microgr/l ] [ Designated as safety issue: Yes ]
- 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 |
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| Netherlands | |
| Sanquin Blood Bank Southeast Region | |
| Maastricht, Netherlands, 6229 GR | |
| Principal Investigator: | Eva Rombout, MD | Sanquin Research and Blood Bank Divisions |
More Information
Additional Information:
No publications provided by Sanquin Research & Blood Bank Divisions
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 May 23, 2013