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Adverse Occurrence type:
6.6% (Kaufman), 0.4% (Cohn). Adverse reaction rate (Kaufman)=10.0%; fever=6.6%, allergic=1.9%, sinus tachycardia=1.8% and 80% associated with fever. Platelet dose per transfusion most important characteristic for AE; ABO matching not associated with AE risk. Grade 1 AE= 6.2%, Grade 2= 3.0%, Grade 3= 0.8%. Platelets stored in additive solution versus plasma AE (Cohn) 1.37% overall AE rate; 0.55% for platelets stored in additive solution vs. 1.37% for platelets stored in plasma. Allergic reactions: 0.29% vs. 0.82%; FNHTR: 0.17% vs. 0.50% platelets stored in additive solution vs. plasma, respectively.
Time to detection:
Alerting signals, symptoms, evidence of occurrence:
Fever, within 4 hours of transfusion (Kaufman)
Demonstration of imputability or root cause:
Multicenter, randomized controlled trial (Kaufman). Retospective review (Cohn)
Kaufman, R.M., Assmann, S.F., Triulzi, D.J., Strauss, R.G., Ness, P., Granger, S. and Slichter, S.J. (2015). Transfusion-related adverse events in the Platelet Dose study. Transfusion 55(1):144-153; Transfusion 54:1927-1934; Cohn, C. S. Stubbs, J., Schwartz, J., Francis, R., Goss, C., Cushing, M., Shaz, B., Mair, D., Brantigan, B. and Heaton, W. A. (2014). A comparison of adverse reaction rates for PAS C versus plasma platelet units. Transfusion 54(8):1927-1934.
Reviewer should determine if there should be a separate entry for the PAS study.