One in four people will need a blood transfusion at some point in his/her live. Blood transfusion save patients life and prevent the complications of severe blood loss in surgeries and cancer patients. In most cases, blood transfusion is safe, preventing negative consequences for patients; however, severe adverse events occasionally occur. Most severe events in blood transfusion come from human errors, when blood transfused do not match the patient´s ABO blood type. These errors affect the recipient's immune system destroying the red blood cells from donor, with severe and harmful consequences even the death of patient. This is known as an acute haemolytic reaction due to ABO incompatible red blood cell (RBC) transfusion. and although unusual (1 in 10.000 RBC transfusions) and avoidable, it is the most frequent cause of death derived from transfusions.
The Para-T System is defined as a medical device to perform a direct, quick and permanent ABO group identification in a bag containing whole blood or red blood cells and/or in the catheter inserted in the vein of a patient, to identify the patient´s ABO group and to prevent incompatible ABO transfusions between the transfusion bag and the recipient.
The Para-T System is based in disposable transfusion set, comprising two parts: the bag device and the patient device and a reading and control unit. By a simple visual inspection or using a reading QR device (PDA that command a solenoid valve), the blood group (A, B, AB or O) of the bag and the blood group of the patient can be permanently compared before transfusion, preventing incompatible ABO transfusions (visually in the cheapest solution or automatically in the more complex solution). The market of the Para-T System can be classified into clinical laboratories, blood banks, hospitals, blood transfusion services and all public organization which help to save lives in low incomes countries and during wars, conflicts and emergencies. It could help to save many lives and is very cost effective.
The following specific goals are pursuit in the Para-T project phase II:
• Product refinement of the biochemical process to identify the blood ABO group using reaction chambers with solid/gel anti-reagents.
• Manufacturing of advance plastic cassettes including the reaction chambers and the readable chambers with a QR code impressed to identify the ABO group and the patient’s identification data.
• Fully adapt our current near-to-industrialized system for industrial production, for which we will work with the technological center AIMPLAS, to manufacture the complete Para-T medical device. The Para-T system compares the ABO group in the donor bag containing Whole Blood or Red Blood Cells (RBCs) and the ABO group in the catheter inserted in the vein of a patient, preventing incompatible transfusions between both. PROPOSIT and AIMPLAS will work together in the design of the pre-industrial production line addressed to facilitate the parallel negotiations with the selected manufacturer.
• Development of the computing program (APP-based) to check compatibility between bag and patient’s cassettes and interconnection with all the additional medical components (magnetic valve release device coupled, luer connections, anti-return valves, etc) to allow a robust and reliable identification system.
• Performing material tests to find the best plastics and anti-reagents for a feasible ABO group checking and later, lab and pilot massive trials with whole blood and RBCs to create evidence of the effectiveness of the Para-T system, improving recognition for the new product to reduce the morbidity and mortality rates of blood recipient patients. Clinical trials with real patients are not necessary to get certification (as there is not interaction between reactants and main blood line due to the anti-return valves) although real patients will provide accredited consent to use their blood for research purposes. The Centre for Hemotherapy and Hemodonation of the Castilla and Leon region has agreed to perform almost 9.000 trials around Para-T with their patients’ blood. The results of these trials will be published in high impact scientific journals, giving a high visibility and prestige to the PROPOSIT Para-T solution among physicians.
• Extend the on-going European Patent to selected countries (10) where the number of donations represent the 83% of the whole donations in Europe. Establish distribution agreements inside Europe after the freedom to operate analysis.
• Overcome the certification barrier. We will take the actions needed to prepare the CE marking with the Medicament Spanish Agency (AEMPS) at the end of the project.
• Accelerate the international expansion by disseminating the results among the doctors, pharma companies, Hematology educators, Hospitals, Transfusion centres, sectorial associations, etc. PROPOSIT is in touch with some key stakeholder showing great interest. Among others, we must highlight the interest of the Minister of Health of Argentina (Prof. Dr. Jorge Daniel Lemus), the Spanish Federation of Blood Donors, the world leading transfusion companies, Terumo and Technoflex, the Richi Foundation of Boston (strong health accelerator), the Spanish Military Transfusion Centre and several hospitals (please check letters of support in annex section 4-5).
• After this stage, private investment will be negotiated (Phase 3), additionally to the investment round we are in process to carry out in the frame of the entrepreneur program called Richi Social Entrepreneur launched by the Richi Foundation (summer 2018). Please check annex in section 4-5.
