100
Participants
Start Date
June 30, 2012
Primary Completion Date
July 31, 2016
Study Completion Date
July 31, 2016
Erythrocytapheresis
"To achieve a blinded randomised trial, apheresis treatment will be used. Those in arm 1 will have erythrocytapheresis reducing iron levels and those in arm 2 will have plasmapheresis and their iron levels will not be reduced.~An apheresis machine will be used to remove red blood cells only from the erythrocytapheresis group. Subjects will have third weekly treatments until SF levels are reduced to \~100 ug/L in accordance with current guidelines."
Plasmapheresis
An apheresis machine will be used to remove blood plasma only from the plasmapheresis group. Those in arm 2 will have the approximate number of episodes of apheresis that would be required to reduce their SF to normal had they been randomised to the true treatment arm. Those in the sham arm will be offered to have venesection at their choice of venue or to have their SF normalised by erythrocytapheresis after the initial blinded part of the study. This will be done because it will not be known for some time if there is benefit from normalisation of SF and therefore leaving people with elevated SF that may be harmful.
Austin Health, Melbourne
Royal Brisbane and Woman's Hospital, Brisbane
Royal Melbourne Hospital, Melbourne
Lead Sponsor
Collaborators (2)
Austin Health
OTHER_GOV
Royal Brisbane and Women's Hospital
OTHER_GOV
Fremantle Hospital and Health Service
OTHER
Melbourne Health
OTHER
The University of Queensland
OTHER
Murdoch Childrens Research Institute
OTHER