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.

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

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12616001307493

Acronym

ADOPT

Enrollment

3035

Registered

2016-09-19

Start date

2016-10-03

Completion date

2017-06-04

Last updated

2021-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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

Interventions

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

Study design

Allocation

Randomised controlled trial

Intervention model

Other

Primary purpose

Prevention

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

30 Years to 70 Years

Healthy volunteers

Yes

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.

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

Outcome results