Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000381482
Ethics application status
Approved
Date submitted
8/04/2025
Date registered
29/04/2025
Date last updated
29/04/2025
Date data sharing statement initially provided
29/04/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
CONSERVE II – Preventing Iatrogenic Anaemia in Malignant Haematology Inpatients: a pilot randomised controlled trial
Scientific title
CONSERVE II – Efficacy of Preventing Iatrogenic Anaemia through Blood Conservation Strategies in Malignant Haematology Inpatients Commencing Chemotherapy Protocols: a pilot feasibility randomised controlled trial
Secondary ID [1] 313975 0
Nil known
Universal Trial Number (UTN)
Trial acronym
CONSERVE II
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Anaemia 336697 0
Condition category
Condition code
Blood 333197 333197 0 0
Anaemia
Blood 333546 333546 0 0
Haematological diseases
Cancer 333547 333547 0 0
Hodgkin's
Cancer 333548 333548 0 0
Leukaemia - Acute leukaemia
Cancer 333549 333549 0 0
Leukaemia - Chronic leukaemia
Cancer 333550 333550 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 333551 333551 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Cancer 333552 333552 0 0
Myeloma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention group: blood sampling frequency will occur as per standard of care. The following interventions will be implemented when blood is required for sampling:
- CVAD discard volume will be reduced from 10mL as per standard of care, to 4mL
- All blood samples taken, excluding blood cultures, will be in small volume blood tubes
- Documentation of all phlebotomy blood loss be recorded by nursing staff on patients’ fluid balance chart
Study interventions include:
- Small volume blood tubes (SST tube 3.5mL, EDTA tube 2mL, Citrate tube 3.5mL)
- Decrease of CVAD discard volume to 4mL
- Documentation of phlebotomy losses
The duration of the intervention period is from enrolment until discharge or 28 days, whichever is less.
Weekly checks will be performed by the study nurse for adherence via medical charts and observation.
Intervention code [1] 330562 0
Prevention
Comparator / control treatment
The control group will receive standard of care blood sampling during their admission. Standard of care blood sampling includes daily blood tests using standard volume blood tubes (SST tube 6mL, EDTA tube 4mL, Citrate tube 3.5mL, EDTA pink tube for group and hold 6mL). 6 - 10mL CVAD discard is taken upon blood collection.
Control group
Active

Outcomes
Primary outcome [1] 341014 0
The primary outcome is study feasibility: The feasibility outcome will be determined based upon the recruitment of participants, retention and attrition of participants, adherence to study protocol and percentage of missing data. This will be assessed as a composite outcome.
Timepoint [1] 341014 0
Recruitment, retention and attrition and missing data will be assessed upon conclusion of recruitment. Protocol adherence will be checked weekly by the study nurse.
Secondary outcome [1] 445789 0
Assess healthcare professionals’ perception of acceptability, appropriateness and feasibility of blood conservation strategies in clinical practice. This will be assessed as a composite outcome.
Timepoint [1] 445789 0
Staff will be provided the feedback measure upon the conclusion of recruitment.
Secondary outcome [2] 445792 0
Assess blood sampling volumes
Timepoint [2] 445792 0
Daily until discharge (or 28 days, whichever is less)
Secondary outcome [3] 445793 0
Assess participants self-reported quality of life and symptomatic anaemia changes to ascertain patients’ perception of intervention effectiveness on symptomatic anaemia. This will be assessed as a composite secondary outcome.
Timepoint [3] 445793 0
Baseline upon enrolment, once per week until discharge (or 28 days, whichever is less).
Secondary outcome [4] 446384 0
Haemoglobin change throughout admission
Timepoint [4] 446384 0
Daily until discharge (or 28 days, whichever is less)
Secondary outcome [5] 446385 0
Red blood cell transfusion use
Timepoint [5] 446385 0
Daily until discharge (or 28 days, whichever is less)
Secondary outcome [6] 446386 0
Total length of inpatient stay to provide estimate of intervention effectiveness
Timepoint [6] 446386 0
Recorded upon discharge

Eligibility
Key inclusion criteria
i. Inpatient on trial wards, and,
ii. 18 years or older, and,
iii. Commencing a chemotherapy protocol (induction or a bone marrow transplant protocol) via intravenous route for haematological malignancy or bone marrow transplant, and,
iv. Any cycle of a patient’s treatment regime where a nadir, or low point of blood cell counts, is expected, and,
v. CVAD insitu.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
i. Under 18 years of age.
ii. Started chemotherapy protocol as an outpatient (e.g. consolidation protocol) and are admitted to hospital (e.g. neutropenic fevers).
iii. Patients transferred from other clinical units (e.g. ICU, CCU) who have commenced chemotherapy protocol in that unit.
iv. Patients receiving treatment for haematological malignancy in any other unit (e.g. CCU, ICU).
v. Patients on an end-of-life pathway.
vi. Cognitive barrier to consent.
vii. Medicare ineligibility.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A participant will be considered enrolled into the study if the participant has met all inclusion criteria and none of the exclusion criteria. The participant will receive a study enrolment number and this will be documented in the participant’s medical record and on all study documents. A separate master log will be created to link the participant’s study number to their medical record. Randomisation will be via a centralised web-based service, which will ensure allocation concealment until study entry.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation). Randomisation will be in a 1:1 ratio between the two groups with randomly varied block sizes of 4, 6 or 8.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This pilot trial is designed for feasibility acquisition, not hypothesis testing. Sample sizes of ~40-50 per group have been suggested as sufficient for this and allow estimate of effect to inform future definitive trials (Hertzog, 2008; Whitehead et al, 2016). A sample of 100 (50 per group) is the target for this trial.
Prior to analysis, data cleaning of outlying figures, missing and implausible data will be undertaken, and a random 5% sample of source data will be re-entered and checked. Feasibility outcomes will be analysed using descriptive statistics (Thabane, 2010). Summary statistics will also be used for clinical data and outcomes. Comparability of groups at baseline will be assessed using clinical parameters. Incidence rates of symptomatic anaemia, transfusion requirements, total length of inpatient stay and patient satisfaction will summarise the impact of the control and intervention group differences. All data will be analysed on an intention to treat and per protocol basis.
The staff survey data will be analysed using descriptive statistics and content analysis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
12/05/2025
Actual
Date of last participant enrolment
Anticipated
3/11/2025
Actual
Date of last data collection
Anticipated
28/11/2025
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 27725 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 43913 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 318662 0
Government body
Name [1] 318662 0
Australian Federal Government Research Training Program Stipend
Country [1] 318662 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
Country
Australia
Secondary sponsor category [1] 321083 0
None
Name [1] 321083 0
Address [1] 321083 0
Country [1] 321083 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317087 0
Metro North Health Human Research Ethics Committee A
Ethics committee address [1] 317087 0
Ethics committee country [1] 317087 0
Australia
Date submitted for ethics approval [1] 317087 0
26/11/2024
Approval date [1] 317087 0
07/02/2025
Ethics approval number [1] 317087 0
HREC/2024/MNH/113566
Ethics committee name [2] 317281 0
Queensland University of Technology University Human Research Ethics Committee
Ethics committee address [2] 317281 0
Ethics committee country [2] 317281 0
Australia
Date submitted for ethics approval [2] 317281 0
10/02/2025
Approval date [2] 317281 0
14/02/2025
Ethics approval number [2] 317281 0
QUTHREC/9573-HE26

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 139958 0
Miss Courtney Black
Address 139958 0
Queensland University of Technology, 149 Victoria Park Road, Kelvin Grove, QLD, 4059
Country 139958 0
Australia
Phone 139958 0
+61 7 3646 7671
Fax 139958 0
Email 139958 0
[email protected]
Contact person for public queries
Name 139959 0
Courtney Black
Address 139959 0
Queensland University of Technology, 149 Victoria Park Road, Kelvin Grove, QLD, 4059
Country 139959 0
Australia
Phone 139959 0
+61 7 3646 7671
Fax 139959 0
Email 139959 0
[email protected]
Contact person for scientific queries
Name 139960 0
Samantha Keogh
Address 139960 0
QUT School of Nursing, Victoria Park Road, Kelvin Grove, Brisbane QLD, 4059
Country 139960 0
Australia
Phone 139960 0
+61 7 3138 3881
Fax 139960 0
Email 139960 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.