In the last century, transfusion medicine had become a semi-clinical discipline. Unlike other pre- and para-clinical specialties, it dealt not only with patient’s samples but also with blood donors. For the blood donor, blood bankers carry out simple procedures like screening and whole blood collection to complex procedures like apheresis, stem cell harvesting, cord blood banking and plasma and platelets pathogen inactivation. Many centers are even taking up complex procedures like therapeutic apheresis and exchange procedures in patients as bedside procedures.
Plasma S/D (Solvent/Detergent) is fresh frozen plasma (FFP) with a high degree of security because it has undergone treatment with solvent/detergent in order to destroy or inactivate many viruses. It is used in critical care for the same indications of FFP:
- Combined deficiency of coagulation factors such as consumption coagulopathies (Disseminated Intravascular Coagulation – DIC) or Coagulopathy due to severe liver failure or massive transfusion.
- Replacement therapy in deficiency of coagulation factors, in emergency situations when the concentrate is not available to a specific coagulation factor, such as the Factor V or Factor XI, or when it is not possible to determine specific factor deficiency.
- Resolution of fibrinolytic activity and rapid resolution of the effect of oral anticoagulants when the action of vitamin K is insufficient for hepatic impairment or in emergency situations.
Debora Lepri. Utilizzo clinico di plasma virus-inattivato. Recenti Progressi in Medicina, 104 2 (1), Marzo 2013
Safe blood is critical to improving patient outcomes. But the continued risk of transfusion-transmitted infections (TTI) from bacteria and emerging pathogens, as well as blood shortages, have brought global attention to the importance of blood safety and availability.
To mitigate the risk of transfusion transmitted infections and to provide more safety for the patients, pathogen inactivation technology was developed.
The INTERCEPT Blood System is a technology for the broad inactivation of viruses, bacteria, protozoa and white blood cells in plasma and platelets for transfusion. The INTERCEPT Blood System effectively inactivates pathogens and white blood cells using a photosensitizer and UVA light to inhibit the replication and transcription of pathogen genomes in a targeted and specific manner while preserving the blood components’ clinical efficacy. It has a broad inactivation capacity combined with a high efficiency. Multiple studies confirmed that the technology is non-toxic for the transfusion recipient with a very high safety margin.
A large number of clinical trials gave evidence that platelets and plasma treated with the INTERCEPT Blood System are safe and efficacious in comparison to untreated blood components.
It was shown that long-term usage of the INTERCEPT Blood System significantly reduces the incidence of both septic transfusion reactions and the transmission of transfusion-transmitted pathogens. Due to its capacity to inactivate white blood cells, the technology is also approved for both replacement of gamma irradiation and replacement of CMV testing, to prevent GvHD and CMV infection. Inactivation of white blood cells also contributes to the observed reduction of non-hemolytic transfusion reactions.
In summary, the INTERCEPT Blood System is an efficient method to provide additional safety to platelet and plasma transfusion recipients. It minimizes the growing risk of transfusion transmitted infections and their potentially fatal consequences. Additionally, for immune-compromised recipients, it minimizes the risks of TA-GvHD and contributes to the reduction of non-hemolytic transfusion reactions.
Benjamin et al., 2017. Hemovigilance monitoring of platelet septic reactions with effective bacterial protection systems. Transfusion 57: 2946-2957
Cazenave et al., 2011. Use of additive solutions and pathogen inactivation treatment of platelet components in a regional blood center: impact on patient outcomes and component utilization during a 3-year period. Transfusion 51: 622-629
Ciaravino, 2001. Preclinical Safety of a Nucleic Acid-Targeted Helinx Compound: A Clinical Perspective. Semin Hematol 38:12-19
Ciaravino et al., 2003. Preclinical safety profile of plasma prepared using the INTERCEPT Blood Sys. Vox Sang 85:171-182
Cid et al., 2012. Therapeutic efficacy of platelet components treated with amotosalen and ultraviolet A pathogen inactivation method: results of a meta-analysis of randomized controlled trials. Vox Sang 103: 322-330 Cid, 2017
Prevention of transfusion-associated graft-versus-host disease with pathogen-reduced platelets with amotosalen and ultraviolet A light: a review. Vox Sang 112: 607-613
Jimenez-Marco et al., 2012. Pathogen inactivation technology applied to a blood component collected from an asymptomatic carrier of Leishmania infantum: a case report. Vox Sang 103: 356-358
Prowse et al., 2013. Component pathogen inactivation: a critical review. Vox Sang 104: 183-199
Rasongles et al., 2009. Transfusion of platelet components prepared with photochemical pathogen inactivation treatment during a Chikungunya virus epidemic in Ile de La Réunion. Transfusion 49: 1089-1093 Schlenke, 2014. Pathogen inactivation technologies for cellular blood components: an update. Transfus Med Hemother 41: 309-325
Swissmedic Annual Report 2012-2016. www.swissmedic.ch
Tice et al., 2007. The pathogen reduction treatment of platelets with S-59 HCl (Amotosalen) plus ultraviolet A light: Genotoxicity profile and hazard assessment. Mut Res 630: 50-68