A multi-centre study of therapeutic efficacy and safety of platelet components treated with amotosalen and ultraviolet A pathogen inactivation stored for 6 or 7 d prior to transfusion.

Bacteria in platelet components (PC) may result in transfusion-related sepsis (TRS). Pathogen inactivation of PC with amotosalen (A-PC) can abrogate the risk of TRS and hence facilitate storage to 7 d. A randomized, controlled, double-blinded trial to evaluate the efficacy and safety of A-PC stored for 6-7 d was conducted. Patients were randomized to receive one transfusion of conventional PC (C-PC) or A-PC stored for 6-7 d. The primary endpoint was the 1 h corrected count increment (CCI) with an acceptable inferiority of 30%. Secondary endpoints included 1- and 24-h count increment (CI), 24-h CCI, time to next PC transfusion, red blood cell (RBC) use, bleeding and adverse events. 101 and 100 patients received A-PC or C-PC respectively. The ratio of 1-h CCI (A-PC:C-PC) was 0·87 (95% confidence interval: 0·73, 1·03) demonstrating non-inferiority (P = 0·007), with respective mean 1-h CCIs of 8163 and 9383; mean 1-h CI was not significantly different. Post-transfusion bleeding and RBC use were not significantly different (P = 0·44, P = 0·82 respectively). Median time to the next PC transfusion after study PC was not significantly different between groups: (2·2 vs. 2·3 d, P = 0·72). Storage of A-PCs for 6-7 d had no impact on platelet efficacy.

Stored red blood cell viability is maintained after treatment with a second-generation S-303 pathogen inactivation process.

BACKGROUND: Transfusion-transmitted infections and immunologic effects of viable residual lymphocytes remain a concern in red blood cell (RBC) transfusion. Pathogen reduction technologies for RBC components are under development to further improve transfusion safety. S-303 is a frangible anchor-linker-effector with labile alkylating activity and a robust pathogen reduction profile. This study characterized the viability of RBCs prepared with a second-generation S-303 process and stored for 35 days. STUDY DESIGN AND METHODS: This was a two-center, single-blind randomized, controlled, crossover study in 27 healthy subjects. S-303 (test) or control RBCs were prepared in random sequence and stored for 35 days, at which time an aliquot of radiolabeled RBCs was transfused. The 24-hour recovery, RBC life span, and in vitro metabolic and viability variables were analyzed. RESULTS: The mean 24-hour RBC recovery and hemolysis of test RBCs were similar to control RBCs and were consistent with the Food and Drug Administration (FDA) guidance for RBC viability. The mean differences in life span and median life span (T(50) ) of circulating test RBCs were 13.7 and 6.8 days, while the mean difference in the area under the curve of surviving RBCs was 1.38%, in favor of control RBCs. There were no clinically relevant abnormal laboratory values after the infusion of test RBCs. All crossmatch assays of autologous S-303 RBCs were nonreactive. CONCLUSIONS: RBCs prepared using the S-303 pathogen inactivation process were physiologically and metabolically suitable for transfusion after 35 days of storage, met the FDA guidance criteria for 24-hour recovery, and did not induce antibody formation.

An active hemovigilance program characterizing the safety profile of 7483 transfusions with plasma components prepared with amotosalen and UVA photochemical treatment.

BACKGROUND: Photochemical pathogen inactivation treatment (PCT) of plasma components with amotosalen and UVA has been implemented in Europe. To establish a postapproval safety database, an active hemovigilance (HV) program utilizing an electronic data capture system (EDCS) was initiated. STUDY DESIGN AND METHODS: The response to transfusion was documented after each PCT-plasma transfusion. The primary outcome was the incidence of acute transfusion reactions (ATRs) within 24 hours of transfusion. An ATR was defined as an adverse event (AE) possibly related, probably related, or related to the PCT-plasma transfusion. For AEs, the following were collected: time of event after transfusion, clinical description, vital signs, clinical and laboratory test results, severity (Grade 0-4), seriousness, and causal relationship to transfusion of PCT-plasma. RESULTS: To date, 3232 patients (59.1% male) with a primary indication for plasma transfusion due to a hematology disorder (23.1%), surgery (32.4%), or a general medical condition (44.4%) received 7483 PCT-plasma transfusions (composed of 19,069 apheresis plasma components). The mean age of the patient population was 57.3 years (2884 adults, 160 children, and 188 infants). ATRs were reported for 8/7483 transfusions (0.11%; 95% confidence interval [CI], 0.03-0.19) and 8/3232 patients (0.25%; 95% CI, 0.08-0.42%). Five ATRs were of Grade 1 severity. The remaining three ATRs were classified as serious. No deaths or episodes of transfusion-related acute lung injury attributed to a PCT-plasma transfusion were reported. CONCLUSION: PCT-plasma transfusions were well tolerated in routine clinical use. The EDCS HV program facilitated collection and reporting of safety information on a real-time basis from multiple sites.