Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001097932
Ethics application status
Approved
Date submitted
29/08/2020
Date registered
21/10/2020
Date last updated
21/10/2020
Date data sharing statement initially provided
21/10/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Quality of life for patients with long term anaemia self-managing red cell transfusions
Scientific title
A mixed-methods pilot feasibility study of self-managing red cell transfusion requirements in chronic anaemia
Secondary ID [1] 302178 0
None
Universal Trial Number (UTN)
U1111-1257-6171
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic anaemia 318845 0
Condition category
Condition code
Blood 316848 316848 0 0
Anaemia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 318480 0
Treatment: Other
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 324960 0
Quality of life as measured by change in FACT-Anaemia score
Timepoint [1] 324960 0
Prior to third transfusion episode
Secondary outcome [1] 386340 0
The ability of the participant self-determined need for transfusion to detect an improvement in fatigue levels following transfusion as measured on a linear analogue scale
Timepoint [1] 386340 0
One day post each transfusion
Secondary outcome [2] 386341 0
Whole blood haemoglobin values.
Timepoint [2] 386341 0
Prior to each transfusion
Secondary outcome [3] 386342 0
Total number of transfusions received during the study period.
Timepoint [3] 386342 0
During 6 months of study from the time of the first transfusion on study until completion of the study 6 months later.
Secondary outcome [4] 386343 0
Intervals between transfusions
Timepoint [4] 386343 0
During 6 months of study from the time of the first transfusion on study until completion of the study 6 months later.
Secondary outcome [5] 386344 0
Activity (steps/day as counted by the participant worn activity tracker)
Timepoint [5] 386344 0
in the 4 days before and 4 days after transfusion
Secondary outcome [6] 386345 0
Resting pulse rate using participant worn activity tracker
Timepoint [6] 386345 0
In the 4 days before and 4 days after transfusion
Secondary outcome [7] 386346 0
Visual analogue score for fatigue
Timepoint [7] 386346 0
Pre transfusion and day 4 post each transfusion
Secondary outcome [8] 386347 0
Participant acceptability of protocol as determined by semi-structured interview.
Timepoint [8] 386347 0
At the completion of the study, expected to be 6 months following the first transfusion, unless stopped earlier by patient, investigator or treating clincian.
Secondary outcome [9] 387356 0
Change in submaximal exercise performance using distance walked in 6 minute walk test.
Timepoint [9] 387356 0
Immediately prior to the first and third transfusion episodes

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
Paired T tests for the primary outcome and secondary outcomes pre and post transfusion. Descriptive stastistics for health diary reported events and themes from semi-structured interviews

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/11/2020
Actual
Date of last participant enrolment
Anticipated
7/02/2022
Actual
Date of last data collection
Anticipated
30/09/2022
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT
Recruitment hospital [1] 17370 0
The Canberra Hospital - Garran
Recruitment postcode(s) [1] 31099 0
2605 - Garran

Funding & Sponsors
Funding source category [1] 306601 0
Government body
Name [1] 306601 0
National Blood Authority
Country [1] 306601 0
Australia
Primary sponsor type
University
Name
Australian National University
Address
Garran Road
ACTON ACT 2601
Country
Australia
Secondary sponsor category [1] 307133 0
None
Name [1] 307133 0
Address [1] 307133 0
Country [1] 307133 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306786 0
ACT Health Human Research Ethics Commitee
Ethics committee address [1] 306786 0
PO Box 11 WODEN ACT 2606
Ethics committee country [1] 306786 0
Australia
Date submitted for ethics approval [1] 306786 0
06/01/2020
Approval date [1] 306786 0
27/08/2020
Ethics approval number [1] 306786 0
2020.ETH.00011

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 105018 0
Dr Philip Crispin
Address 105018 0
Haematology Department
Canberra Hospital
Yamba Drive
Garran ACT 2605
Country 105018 0
Australia
Phone 105018 0
+61251243964
Fax 105018 0
Email 105018 0
philip.crispin@act.gov.au
Contact person for public queries
Name 105019 0
Dr Philip Crispin
Address 105019 0
Haematology Department
Canberra Hospital
Yamba Drive
Garran ACT 2605
Country 105019 0
Australia
Phone 105019 0
+61 251243964
Fax 105019 0
Email 105019 0
philip.crispin@act.gov.au
Contact person for scientific queries
Name 105020 0
Dr Philip Crispin
Address 105020 0
Haematology Department
Canberra Hospital
Yamba Drive
Garran ACT 2605
Country 105020 0
Australia
Phone 105020 0
+61251243964
Fax 105020 0
Email 105020 0
philip.crispin@act.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Few patients at single centre may compromise privacy


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.