Usually, treatment for high levels of iron caused by haemochromatosis involves the frequent removal of blood until the amount of iron is reduced to normal levels. This treatment is called venesection or phlebotomy.
To be as certain as possible that any change in symptoms is due to the reduction in iron levels, it is important that the people participating in the research project are not aware of what group they are in and whether their iron levels have been reduced or not. We have devised a way of doing this by using a treatment called apheresis.
People who are eligible to take part in the study will be randomly allocated (like tossing a coin) to one of the two groups and when the apheresis treatment is done, they will not be able to see the needle in the arm or the apheresis machine.
In apheresis, blood is removed from the arm and enters a machine. The machine removes the red blood cells (which contain iron) and then returns the blood to the body. Therefore if red blood cells are removed and the fluid part of the blood is returned to the arm, body iron level will reduce (group 1). If the fluid part of the blood is removed and the red blood cells are returned to the arm, then the body iron levels will not be reduced (group 2). Following the study, those in group 2 will be offered apheresis or venesection at their choice of venue to have their iron levels reduced to normal.
This research project will compare symptoms in people who have had their iron levels reduced (group 1), to those who have not had their iron levels reduced (group 2). This will be done by asking participants to complete a questionnaire, have two blood tests and a liver ultrasound scan at the beginning and at the end of the study period. Importantly, this study will answer the question; how do we treat people with moderate iron overload?
- One apheresis treatment removes up to three times as much iron as one venesection treatment.
- Therefore up to 66% fewer treatments are needed when using apheresis than if treated by standard venesection.
Participants in group 2 who do not have their iron levels reduced and then choose to have apheresis after finishing the study, will have less treatments than if they had venesection.