None listed
Conditions
Brief summary
The study will evaluate the feasibility of a patient self-directed transfusion strategy, which it is expected will tailor the benefit to individual needs. People with anaemia on chronic transfusion regimens will be recruited. After a baseline assessment and education, they will have their regular transfusion as prescribed by their doctor and assessments repeated. They will then keep a symptom diary, and when they feel they need a transfusion, asked to contact the study team who will arrange daily red cell transfusions until the recipient feels that they have satisfactorily controlled their symptoms, or where they feel there has been no improvement with additional transfusions. The study will evaluate quality of life, exercise tolerance before and after transfusion, the haemoglobin at which patients choose to have transfusions and feel that they have reached their maximum benefit. There will also be patient interviews at the end of the study to assess acceptability of the self-directed approach.
Interventions
People with chronic anaemia requiring transfusion will be asked to determine when they feel the need for red cell transfusions based on their symptoms alone, which will be undertaken. Haemoglobin concentrations will be measured, but participants will be asked to decide when they need a transfusion blinded to these results. Transfusion of a unit of blood will occur daily until symptoms are controlled initially, with subsequent red cell dosing based on the haemoglobin level that led to symptom con
People with chronic anaemia requiring transfusion will be asked to determine when they feel the need for red cell transfusions based on their symptoms alone, which will be undertaken. Haemoglobin concentrations will be measured, but participants will be asked to decide when they need a transfusion blinded to these results. Transfusion of a unit of blood will occur daily until symptoms are controlled initially, with subsequent red cell dosing based on the haemoglobin level that led to symptom control with the first transfusion. Participants will be asked to undertake quality of life surveys, and interview and wear an activity and pulse tracker each day, as well as undertake a short submaximal exercise test (6 minute walk test) prior and after the first and third transfusions.The study will continue for 6 months.
Sponsors
Australian National University
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Be 18 years of age or older; 2. Have a benign or malignant haematological disorder requiring recurrent transfusions predominantly in an outpatient setting; 3. Have an expected ongoing need for transfusion over at least the next three months; 4. Have provided fully informed consent to the study, or have declined to participate in the full study, but have provided consent for a single interview on their reasons for non-participation.
Exclusion criteria
1. Lacking capacity to provide informed consent; 2. Have not provided consent to any aspect of the study; 3. Have transfusions for the treatment of sickle cell disease or thalassaemia; 4. Unable to speak or read English (FACT-An and interviews are in English)
Outcome results
None listed