An active haemovigilance programme characterizing the safety profile of 7437 platelet transfusions prepared with amotosalen photochemical treatment.

摘要: BACKGROUND: An active haemovigilance programme was implemented to survey adverse events (AE) associated with transfusion of platelets photochemically treated amotosalen and ultraviolet A (PCT-PLT). The results 5106 transfusions have already been reported. Here we report the an additional 7437 PCT-PLT transfusions. METHODS: focus this ongoing is document all AEs transfusion. Data collected for include: time event after starting transfusion, clinical descriptions, vital signs, from radiographs bacterial cultures, severity (Grade 0-4) causal relationship RESULTS: One thousand four hundred patients (mean 60 years, range 1-96) received majority (53.4%) had haematology-oncology diseases required conventional chemotherapy (44.8%) or stem cell transplantation (8.6%). Sixty-eight were AE. Acute reactions (ATR), classified as AE possibly related, probably related infrequent (n = 55, 55/7437 0.7%) most Grade 1 severity. Thirty-nine (39/1400 2.8%) experienced one more ATRs. frequently reported signs/symptoms chills, fever, urticaria, dyspnoea, nausea vomiting. Five considered severe (> 2); however, no found. Repeated exposure did not increase likelihood ATR. No cases transfusion-related acute lung injury deaths due CONCLUSIONS: Routine well-tolerated in a wide patients. ATRs mild