Mi-iron - Moderately Increased Iron - is Reducing Iron Overload Necessary?

NACompletedINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

June 30, 2012

Primary Completion Date

July 31, 2016

Study Completion Date

July 31, 2016

Conditions
Hereditary Haemochromatosis
Interventions
PROCEDURE

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."

PROCEDURE

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.

Trial Locations (3)

3081

Austin Health, Melbourne

4072

Royal Brisbane and Woman's Hospital, Brisbane

Unknown

Royal Melbourne Hospital, Melbourne

All Listed Sponsors
collaborator

Austin Health

OTHER_GOV

collaborator

Royal Brisbane and Women's Hospital

OTHER_GOV

collaborator

Fremantle Hospital and Health Service

OTHER

collaborator

Melbourne Health

OTHER

collaborator

The University of Queensland

OTHER

lead

Murdoch Childrens Research Institute

OTHER