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Trial registered on ANZCTR


Registration number
ACTRN12616001307493
Ethics application status
Approved
Date submitted
4/08/2016
Date registered
19/09/2016
Date last updated
10/12/2020
Date data sharing statement initially provided
25/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A trial to investigate the different experiences of first time blood donors over 30 years of age who donate whole blood or who donate plasma by apheresis.
Scientific title
A vanguard multicentre, step wedged cluster randomised trial to assess the tolerability of plasmapheresis versus whole blood in first time donors before expansion to a national roll out
Secondary ID [1] 289748 0
None
Universal Trial Number (UTN)
U1111-1185-7095
Trial acronym
ADOPT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Blood Donation 299597 0
Condition category
Condition code
Other 299717 299717 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study will compare the feasibility, tolerability and acceptability of offering New Donors (blood donors who have no record of having donated previously in Australia) aged between 30 years and 70 the option to choose between two donation types (1) whole blood OR (2) Plasma by Apheresis

Allocation:
a. Inbound Calls: New Donors who meet the inclusion criteria who book appointments at one of the 10 participating Donor Collection Centres via the National Call Centre (NCC) will be offered by a call centre agent the choice to donate whole blood or Plasma by apheresis
b. Outbound Calls: New Donors who meet the inclusion criteria who book appointments at one of the 10 participating Donor Collection Centres via the Blood Service Website will be contacted by a NCC agent and offered the choice to donate whole blood or Plasma by apheresis
c. Walk Ins: New Donors who meet the inclusion criteria who present at one of the 10 participating Donor Collection Centres will be offered the choice to donate whole blood or Plasma by apheresis by Donor Centre Staff.

Apheresis is the process of collecting blood components, like plasma using a cell separating machine. During a plasma donation, blood is drawn from the donation arm by a pump into a sterile single use disposable kit inside the cell separating machine. Inside the apheresis machine there is a blood processing chamber that centrifuges the blood, separating it into layers. Red cells are the heaviest and sit at the bottom, platelets and white cells are in the middle and plasma is at the top as it is the lightest. The apheresis machine is programmed to detect the plasma and divert it into a collection bag with the rest of the blood given back to the donor (red cells, white cells and platelets). This cycle is repeated until the desired collection volume is achieved. A small amount of citrate anticoagulant is mixed with each withdrawal of blood to prevent clotting. This is controlled by the cell separator. The anticoagulant works by inactivating calcium, which is require for clotting to occur. The donor will receive a small amount of anticoagulant as it is returned with the components that are not being collected. The cell separator also infuses 500ml of saline solution to the donor, to aid in the replacement of fluid.

The plasma collection volume for new donors is 13% of their Total blood Volume(TBV) capped at 750ml. TBV is estimated using the modified Nadler's equation


The plasma donation is collected over 45minutes, The entire donation process including registration, interview and refreshment time after donations usually takes around 1.5 hours
Intervention code [1] 295394 0
Other interventions
Comparator / control treatment
Control: Whole Blood Donation.
Intervention: Plasmapheresis as a first donation type

Currently the Australian Guidelines for Selection of Blood Donors states that all blood donors must have donated at least 1 whole blood donation prior to being offered the choice to donate plasma by apheresis. Therefore Plasmapheresis as a first donation type is the intervention under investigation
Control group
Active

Outcomes
Primary outcome [1] 299042 0
Retention rates (rates of return for subsequent donations) between new donors who donate whole blood and new donors who donate plasma by apheresis.

Data will be obtained through linkage to Blood Service Records
Timepoint [1] 299042 0
6 months from the initial donation date
Secondary outcome [1] 325951 0
Difference between whole blood and plasma groups vasovagal reactions.
Assessment of Vasovagal Reactions (VVRs) follows the International Society of Blood Transfusion (ISBT) guidelines for surveillance of complications related to Blood Donation.

Vasovagal reactions are self reported by donors or observed by attending donor centre staff. Vasovagal reactions are divided in two main subgroups
1. Without loss of consciousness (LOC) or
2. With loss of consciousness (LOC)

and further assessed based on time from symptom onset to time of full recovery, reported by donor or a attending blood service staff member(s)
Timepoint [1] 325951 0
7 days post initial donation date
Secondary outcome [2] 325952 0
Difference between whole blood and plasma groups Blood Donor Reaction Inventory (BDRI) scores.

Donors will rate on a Likert Scale 1-5, How they feel post donation in the following 4 symptom areas Faintness, Dizziness, Weakness and Light Headedness
Timepoint [2] 325952 0
7 days post initial donation date
Secondary outcome [3] 325953 0
Difference between whole blood and plasma groups in donor satisfaction as reported via study specific survey
Timepoint [3] 325953 0
7 days post initial donation date
Secondary outcome [4] 325956 0
Difference between whole blood and plasma groups in intention to donate in the future as reported via study specific survey
Timepoint [4] 325956 0
7 days post initial donation date
Secondary outcome [5] 344791 0
Difference between whole blood and plasma groups in retention at 12 months
Timepoint [5] 344791 0
12 months post initial donation date
Secondary outcome [6] 344792 0
Difference between whole blood and plasma groups in retention at 24 months
Timepoint [6] 344792 0
24 months post initial donation date

Eligibility
Key inclusion criteria
Cluster (Blood Collection Centre)
Inclusion Criteria
1. Sufficient size to recruit 20 new donors a month over a 6- 7 month period and
2. a historical measure over a 18 month period (1/1/2014 to 31/06/2015) of
a) Greater than 10% first time whole blood donors converted to plasma
b) Greater than a 60% return rate for plasma to plasma donations
c) Greater than a 55% total retention rate for all donation types (WB, PLS, PLT)

Participant (Blood Donor)
Inclusion Criteria
1. Adults 30 years or over and less than 71 years
2. New Donor (someone who has never registered to donate)
3. Generally eligible for blood donation as per the current GSBD
4. Written consent for General Donation and written consent for Apheresis for plasma
donations.
Minimum age
30 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Cluster (Blood Collection Centre)
Exclusion Criteria
1. Participation in another research study (R&D or Marketing) that may interfere with donor
recruitment and the outcomes under investigation
2. Donor Services Leadership team consider the donor centre not appropriate for participation (e.g.: centre undergoing renovations, relocation)

Participant (Blood Donor)
Exclusion Criteria
1. Not eligible for any type of blood donation as per the current Guidelines for Selection of Blood Donors (GSBD)
2. Participation in a concurrent interventional medical investigation or clinical trial. Participants in observational, natural history and/ or epidemiological studies not involving an intervention are eligible. Participation in another Blood Service study at the time of donation is not permitted.
3. Vein unable to be palpated under pressure (BP cuff, tourniquet) during interview and in
donation chair

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)
Allocation is not Concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Donor Collection Centres (Cluster) will be randomised via a Simple randomisation scheme using computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Step Wedged Cluster Randomised Trial - Each participating donor collection centre will be randomised to commence the intervention (offer of plasma apheresis in first time donors) at a specific time point during the 7 month recruitment phase.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/10/2016
Actual
3/10/2016
Date of last participant enrolment
Anticipated
Actual
4/06/2017
Date of last data collection
Anticipated
4/12/2019
Actual
4/12/2019
Sample size
Target
1400
Accrual to date
Final
3035
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA,VIC

Funding & Sponsors
Funding source category [1] 294135 0
Charities/Societies/Foundations
Name [1] 294135 0
Australian Red Cross Blood Service
Country [1] 294135 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Australian Red Cross Blood Service
Address
National Office
Level 3, 417 St Kilda Rd
Melbourne VIC 3004
Australia
Country
Australia
Secondary sponsor category [1] 292965 0
None
Name [1] 292965 0
NA
Address [1] 292965 0
NA
Country [1] 292965 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295548 0
Australian Red Cross Blood Service Ethics Committee
Ethics committee address [1] 295548 0
C/- Sydney Processing Centre
17 O'Riordan St
Alexandria NSW 2015
Ethics committee country [1] 295548 0
Australia
Date submitted for ethics approval [1] 295548 0
10/06/2016
Approval date [1] 295548 0
02/08/2016
Ethics approval number [1] 295548 0

Summary
Brief summary
Global demand for plasma-derived products including intravenous immunoglobulin (IVIg) continues to grow steadily. In contrast, medical advances and improvements in patient blood management have decreased requirements for red cell products. With less collections required to meet red cell inventory, the amount of fractionated plasma available from whole blood donations has been reduced. These factors have shifted donor centre operations from a primary focus on whole blood collections to an increased effort to recruit and retain plasmapheresis donors to meet future demand.

Australian Blood Service policy currently requires that blood donors give at least one whole blood donation before entering the plasmapheresis programme. The rationale behind this policy has been to determine donor suitability for apheresis donation (e.g. blood type, vein suitability) and to minimise vasovagal reactions and resulting donor drop-outs and deferrals. Similar policies for recruitment to plasmapheresis donation panels exist overseas with only the United States and the United Kingdom Blood Services permitting first-appointment apheresis donation. Consequently, little data exists regarding tolerability and donor acceptance of first-attendance plasma donation – particularly for voluntary non-remunerated blood donors.

With improvements in plasmapheresis safety (e.g. saline compensation), and concern over iron depletion among whole blood donors, a review of Australian plasmapheresis donation policy is warranted. Importantly, there is no regulatory barrier to implementing first appointment plasmapheresis donation.

If tolerable and acceptable to donors, first-attendance plasmapheresis donation could help to:
1. Increase the plasmapheresis panel and overall collections of plasma for fractionation
2. Reduce the number of first attendance red cell deferrals
3. Reduce reliance on fractionated whole blood donations for collection of plasma
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 67662 0
Prof David Irving
Address 67662 0
Australia Red Cross Blood Service
Sydney Processing Centre
17 O'Riordan St
Alexandria NSW 2015
Country 67662 0
Australia
Phone 67662 0
+61 2 9234 2398
Fax 67662 0
Email 67662 0
[email protected]
Contact person for public queries
Name 67663 0
Elizabeth Knight
Address 67663 0
Australia Red Cross Blood Service
Sydney Processing Centre
17 O'Riordan St
Alexandria NSW 2015
Country 67663 0
Australia
Phone 67663 0
+61 2 9234 2386
Fax 67663 0
Email 67663 0
[email protected]
Contact person for scientific queries
Name 67664 0
Barbara Bell
Address 67664 0
Australia Red Cross Blood Service
Sydney Processing Centre
17 O'Riordan St
Alexandria NSW 2015
Country 67664 0
Australia
Phone 67664 0
+61 2 9234 2296
Fax 67664 0
Email 67664 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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
SourceTitleYear of PublicationDOI
EmbaseOffering new and returned donors the option to give plasma: implications for donor retention and donor adverse events.2021https://dx.doi.org/10.1111/vox.12977
N.B. These documents automatically identified may not have been verified by the study sponsor.