Not Yet RecruitingPhase 4ACTRN12620001097932

Quality of life for patients with long term anaemia self-managing red cell transfusions

A mixed-methods pilot feasibility study of self-managing red cell transfusion requirements in chronic anaemia


Sponsor

Australian National University

Enrollment

15 participants

Start Date

Nov 3, 2020

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria4

  • Be 18 years of age or older;
  • Have a benign or malignant haematological disorder requiring recurrent transfusions predominantly in an outpatient setting;
  • Have an expected ongoing need for transfusion over at least the next three months;
  • 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 Criteria4

  • Lacking capacity to provide informed consent;
  • Have not provided consent to any aspect of the study;
  • Have transfusions for the treatment of sickle cell disease or thalassaemia;
  • Unable to speak or read English (FACT-An and interviews are in English)

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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 conc

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.


Locations(1)

The Canberra Hospital - Garran

ACT, Australia

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ACTRN12620001097932