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TRANSfusion and transplantation: PrOtection and SElection of donors [TRANSPOSE] [738145] - Project
Project abstract

Over five million patients in the EU annually receive transfusions or transplantations of substances of human origin (SoHO): blood components, plasma derived medicines, tissues & (stem) cells, germ cells for assisted reproductive technologies and organs. These treatments depend heavily on the availability of SoHO obtained from more than 13 million donors. Obviously, donor availability is the most vulnerable link in assuring these treatments.

Procedures to collect SoHO, including donor selection and the actual collection or procurement, are regulated in the EU by several directives. In addition, the European Directorate for the Quality of Medicines & Health Care (EDQM) publishes recommendations (Guides) relating to the preparation, use and quality assurance of SoHO forming a basis for standard operating procedures. From this, one could infer that practice throughout Europe is harmonised. However, implementation of the directives and Guides in Member states has resulted in diverging donor selection and protection policies. Expert opinions, lacking quantitative risk-based selection criteria, and prompting a one-size-fits-all approach, have in fact lead to inflexibility and inconsistency.

TRANSPOSE aims at a structured, alternative approach to construct risk-based Guidelines for the selection and protection of donors. To this end, TRANSPOSE will involve a massive pool of experts and take stock of current practices and scientific insights.

TRANSPOSE may facilitate the process of revising related EU Directives. Moreover, the developed guiding principles and Donor Selection & Protection Guidelines will assist EU member states to implement policies in a consistent and clear-cut way. Finally, a standard Donor Health Questionnaire with carefully guided local/regional/national customization will become available, which can be used widely and will enable comparisons between Member States on the prevalence of certain risks and risky behaviours throughout Europe.

Summary of context, overal objectives, strategic, relevance and contribution of the action

TRANSPOSE

TRANSPOSE is the project, which will add to harmonising European donor selection and protection
policies, whilst keeping adequate health & safety protection of the recipient. TRANSPOSE will consist
of four substantive, interrelated Work Packages (WPs) in order to reach the general objective of a
coherent set of donor selection and protection guidelines:
- WP4 Inventory of Donor Selection & Protection Practices: i.e. the use of existing guidelines &
tools, donor health & lifestyle questionnaires, through interviews with staff involved across the EU
and with a wide range of specific personnel, and a survey in Member States;
- WP5 Development of Donor Selection & Protection Guidelines, with a focus on development of
minimal donor selection criteria, evaluation of additional criteria and validation of new and
existing criteria to determine effectiveness;
- WP6 Development of a Standard Donor Health Questionnaire (DHQ);
- WP7 Training Course/Workshop on the Use of the Guiding Principles, Guidelines and the DHQ. In
conjunction, three WPs on coordinating, disseminating, and evaluating this project will complete
TRANSPOSE.
Consecutive WPs follow a logical timeline where WPs -especially WPs 4 through 7- show overlap in
time as well as partners, as to allow for a proper exchange of the information needed to conduct each
WP adequately.


The impact of the outcomes of TRANSPOSE will be threefold.

First, outcomes are expected to be of help in the revising process of related EU Directives.

Second, the set of guiding principles and Donor Selection & Protection Guidelines will facilitate EU
member states to take a next step in implementing donor selection and protection policies in a
consistent and clear-cut way to the benefit of both donors and recipients of SoHO.

Third, a standard Donor Health Questionnaire with carefully guided local/regional/national adjustments
will become available, which can be used widely and will consequently enable comparisons of the
prevalence of certain risks and risky behaviours throughout Europe.
Given that each year five to ten out of 1000 persons need a transfusion, or a transplantation, and at
minimum an estimated one in five persons can expect to be confronted with some kind of transfusion
or transplantation of SoHO during their lives, TRANSPOSE’s impact is obvious and certainly presents
important societal relevance.

Methods and means

WP4:
D4.1 - questionnaires were put together with experts in the field of blood, plasma, stem cells, ART and tissues. These questionnaires were sent to experts from several European countries and compiled into a report. Additionally, these results were discussed in a focus group during our Consortium meeting in Copenhagen in September.

WP5:
D5.1 -
The following stakeholders participated in this work package: Region Hovedstaden, Denmark (work package leader); Sanquin, The Netherlands; Italian National Blood Centre, Establissement Français du Sang, NHS Blood and Transplant, UK; CSL Plasma Gmbh; Aarhus Universitets Hospital, Denmark; Sihtasutus Pohja-Eesti Regionaalhaigla, Estomia; Banc de Sang I Teixits, Spain; Blutspendedienst Des Bayerischen Roten Kreuzes Ggmbh, Germany; University of Cambridge; Bioef Fundacion Vasca de Innovacion e Investigation Sanitarias, Spain; Suomen Punainen Risti, Finland; Ministry of Health, Malta; Zavod Republike Slovenije za Transfuzijsko Medicino, Slovenia; Osterreichisches Rotes Kreuz, Austria; Universitaetsklinikum Hamburg Eppendorf, Germany; Viesoji Istiaga Nacionalinis Kraujo Centras, Lithuania. TRIP foundation, national office for hemo/ and biovigilance , The Netherlands
The work package was divided into three subgroups; one identifying risk-assessment tools for the WP’s further work and two identifying donor and recipient risks respectively. We initiated a survey across all TRANPOSE participants to identify relevant donor and recipient risks. This was finalized in a series of teleconferences and a workshop which included stakeholders from both WP5 and WP4, the latter WP being responsible for collecting donor health questionnaires from all participating partners and compare differences and similarities. In parallel, national or regional reports on adverse reactions and events in donors and recipients from the last three years were collected from TRANSPOSE participating countries for whole blood, plasma, tissue - the latter including Assisted reproductive therapy (ART), bone (living donors), ocular tissue, connecting tissue, tendons, heart valves etc. (deceased donors) and stem cells. Notified transfusion transmitted infections (TTI) where the follow-up testing of the products found an imputability of 0 was not included. The European commission’s reports on haemo- and biovigilance were not included, since this would risk including the same data twice. We chose to include both serious and non-serious adverse reactions and events.
Results are presented in detail in the two-following manuscripts which will be submitted for publication following this report.

Work performed during the reporting period

WP1: Coordination of the project – Sanquin, The Netherlands
The WP1 has to monitor the objectives, milestones, deliverables, logistics and time-frame of the TRANSPOSE Project.
During these first months WP1 organized the kick-off meeting that was held in Amsterdam last21st and 22nd of September and the meeting that was held in Helsinki last 11th of April. WP1 team has also played the coordinating role of the project, keeping track of the advancement status of all other WPs and helping them to meet the deadlines.

WP1 was then active in the day-to-day work of project reporting on content of activities, also with EU Commission, and in distributing grant money.
Last but not least the WP1 team also drafted the text of a Consortium Agreement that sets out a series of internal arrangements between the Transpose Participants. The Consortium Agreement, which will be soon implemented, will cover various aspects of the project, i.e. internal organization and settlement of internal disputes.


WP2: Dissemination of the Project – CNS, Italy
The WP2 has to manage all the communication and dissemination activities, including the outputs, related to TRANSPOSE
The WP2 laid out a dissemination plan that includes the target groups and a communication strategy based on the realization of a leaflet, a dedicated website and publications in international scientific journals as well as a final laymen report on the milestones and deliverables achieved during the project lifetime.

Since the beginning of the project, and according to the plan, the WP2 team worked on the realization and setting up of www.transposeproject.eu, a website that is the official communication channel of the project addressed to the general public and stakeholders. It will be used also for internal discussions and documents upload by the Consortium, through a proper forum section.
The WP2 team also worked on a leaflet, a brief description of the specific goals of the project, that was published on the download section of the website, and on the realization of dedicated power point and word templates to be used by the project partners.

WP3: Evaluation of Transpose – EFS, France
The WP3 has to carry out a full evaluation of the project, examining daily activities, project results, meeting reports and all relevant data about Transpose.
WP3 only recently has begun its evaluation of the TRANSPOSE Project, starting with evaluating the 6 months progress report that the Coordinator put together. This template has been accepted as the template which will be used for such Working Package evaluation.
In addition, a Quality and Evaluation Plan has been drafted with the help of the Coordinator.
WP3 team will also continue to connect with other colleagues who have the experience of evaluating a European programme to gather information about what methodologies were used in those programmes to then create a strong evaluation framework to be used in the TRANSPOSE Project.

WP4: Inventory of Donor Selection and Protection Practices – UCAM, United Kingdom
The WP4 has to draw up an inventory of all current practices in donor selection and protection and then gather knowledge and expert opinions about benefits and pitfalls of specific practices.
In these first months, the WP4 team completed the practices recollection on different substances of human origins (SoHO’s): plasma, stem cells, blood, tissues and Assisted Reproductive Technology (ART).
WP4 then created questionnaires for any SoHO’s sub-groups and sent them out for feedback to a group of experts. This information will be put in a database and thoroughly discussed along with WP5 an WP6 members in the meeting that will be held next September in Copenhagen.

WP5: Development of donor selection and protection guidelines – Region H, Denmark
WP5 has to identify current donor and recipient risks for blood, tissue and cells and then to produce guidelines for donor selection criteria.
The WP was divided into 3 subgroups, one to

The main output achieved so far and their potential impact and use by target group (including benefits)

The main outputs have so far been


WP4
In-depth inventory of current practices in donor selection and protection: i.e. the use of existing guidelines & tools, donor health & lifestyle questionnaires, through interviews with staff involved across the EU and with a wide range of specific personnel, and a survey in Member States.

Output: Qualitative in-depth interviews with key persons from SoHO organisations Five to ten interviews identifying all key topics and points of awareness, judged relevant by 80% of the team members
Output: Quantitative questionnaires to professionals from SoHO collection institutions. 5 questionnaires for each SoHO (blood, plasma, tissues, ART and stem cells) have been sent to 130 expets both in the TRANSPOSE project as well as external experts.

These inventories collecting feedback will allow us in TRANSPOSE to put together the current opinions of experts and provide WP5 and WP6 with the deedback they need to propose new Guiding Principles and Donor Health Questionnaire.

WP5
Donor risks were identified from an inventory of national/regional reported serious and non-serious adverse reactions and events, each participating country or region providing the last three published reports from the years 2014-2017. In parallel, experts were asked a series of open questions to identify risks both well described in literature and those that are not currently not part of donor vigilance.

Achieved outcomes compared to the expected outcomes

.

Dissemination and evaluation activities carried out so far and their major results

The WP2 has to manage all the communication and dissemination activities, including the outputs, related to TRANSPOSE

The WP2 laid out a dissemination plan that includes the target groups and a communication strategy based on the realization of a leaflet, a dedicated website and publications in international scientific journals as well as a final laymen report on the milestones and deliverables achieved during the project lifetime.
Since the beginning of the project, and according to the plan, the WP2 team worked on the realization and setting up of www.transposeproject.eu, a website that is the official communication channel of the project addressed to the general public and stakeholders. It will be used also for internal discussions and documents upload by the Consortium, through a proper forum section.
The WP2 team also worked on a leaflet, a brief description of the specific goals of the project, that was published on the download section of the website, and on the realization of dedicated power point and word templates to be used by the project partners.

Details
Start date: 01/09/2017
End date: 29/02/2020
Duration: 30 month(s)
Current status: Finalised
Programme title: 3rd Health Programme (2014-2020)
EC Contribution: € 522 170,23