|
|
![]() |
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
|||||||||||||||||||||||||||||||||||||||||||||
| Descriptive Information Fields | |||||
| Brief Title † | Haemochromatosis:Phlebotomy Versus Erythrocytapheresis Therapy | ||||
| Official Title † | Therapeutic Erythrocytapheresis as Treatment for Hemochromatosis Patients. | ||||
| 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. |
||||
| Study Phase | Phase III | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Single Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study | ||||
| Primary Outcome Measure † | frritine | ||||
| Secondary Outcome Measure † | |||||
| Condition † | Hemochromatosis | ||||
| Intervention † | Procedure: Phlebotomy, erythrocytapheresis | ||||
| MEDLINE PMIDs | |||||
| Links | Related Info ![]() |
||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Recruiting | ||||
| Enrollment † | 40 | ||||
| Start Date † | October 2004 | ||||
| Completion Date | September 2006 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† |
|
||||
| Location Countries † | Netherlands | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00202436 | ||||
| Organization ID | PPO-C- 03-006 | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | Sanquin Research & Blood Bank Divisions | ||||
| Collaborators †† | Maastricht University Medical Center Atrium Medical Center Radboud University |
||||
| Investigators † |
|
||||
| Information Provided By | Sanquin Research & Blood Bank Divisions | ||||
| Verification Date | February 2007 | ||||
| First Received Date † | September 13, 2005 | ||||
| Last Updated Date | February 26, 2007 | ||||