What is Myelodysplastic Syndrome (MDS)?
Myelodysplastic syndromes (MDS or myelodysplasia) are a group of blood diseases which affect the production of normal blood cells by the bone marrow. MDS occurs because of mutations (or changes) developing in one or more of the genes that control blood cell development. This results in the abnormal growth of blood stem cells and lower numbers of healthy red blood cells (which carry oxygen), white blood cells (which fight infection) and platelets (which help the blood to clot). People with MDS frequently report symptoms of fatigue due to anaemia, and may develop infections, easy bruising and bleeding.
For more information about MDS, visit the Leukaemia Foundation website.
What is the purpose of the REDDS-2 Study?
People with MDS may be given regular blood transfusions to treat anaemia and prevent complications (e.g. heart failure) and anaemia symptoms (fatigue, shortness of breath). The need for blood transfusions is usually guided by the results of a laboratory test called haemoglobin (Hb). Transfusions are usually given when a patient’s Hb drops below 80g/L. In most cases, several units of red blood cells are transfused every two to four weeks to raise the Hb to around 85-100g/L, but this varies.
Between transfusion appointments, some people may still feel tired or short of breath due to the fall in their Hb levels. It is possible that patients with MDS may feel better and have an improved quality of life if they have more frequent transfusions with a small number of units of blood (e.g. 1-2 units of blood given every week) to keep their Hb level at a more stable level between transfusion appointments.
The purpose of this small study is to find out if giving blood transfusions at weekly intervals will work and is safe. The results may also give us information on whether weekly transfusions improve a patient’s general well-being, physical function or quality of life. This type of study is called a feasibility study, which describes a short trial that will help us decide whether a larger study is worthwhile and will work.
What is involved?
There are two parts to this research project:
Part 1 of the project is a Clinical Trial where we will compare your usual transfusion schedule to a personalised weekly transfusion schedule.
Part 2 of the project is an optional 30 to 45 minute interview to discuss and explore your experiences of the weekly transfusion schedule, as compared to your previous schedule. This includes exploring your personal preferences, the impact of weekly transfusion schedule on your daily life and activities, and any aspects of the trial that you disliked or enjoyed. Your responses and views will help us build a more complete picture of the disadvantages, advantages and impact of the weekly transfusion schedule from a patient’s perspective.
What information do we collect?
If your hospital is contributing to the REDDS-2 Study and you meet the eligibility criteria, clinical or research staff may ask you to participate in this Study. With your consent, they will collect your health information directly from you and the hospital medical records and enter it into a secure database. You will be given a Trial Number so that your name is never provided to the researchers.
Information collected:
- Your medical history, symptoms and laboratory test results
- Information on your past transfusions and any transfusions you receive while you are on the trial
- Your response to your usual transfusion schedule and the weekly transfusion schedule
- Results of your physical function tests (hand-grip strength, a 6-minute walk test, data from a wrist-worn step-counter)
- Your quality of life while participating in the trial. You will be asked to complete voluntary surveys from time to time about this
- Blood samples for further analysis (optional)
How we protect your privacy
Your privacy is extremely important to us. Your information will only be used for research purposes. No analysis or public reports will contain information that could identify you.
This Study has also been reviewed by the participating hospital's Human Ethics Committee.
Your information is securely stored at Monash University in Australia. The information is restricted to appropriate hospital staff and research officers who are committed to maintaining confidentiality.
If you would like to be involved in this study or would like more information, please contact us.