An active haemovigilance programme characterizing the safety profile of 7437 platelet transfusions prepared with amotosalen photochemical treatment.
Osselaer, J. C. 1; Cazenave, J. P. 2; Lambermont, M. 3; Garraud, O. 4; Hidajat, M. 5; Barbolla, L. 6; Tardivel, R. 7; Defoin, L. 1; Waller, C. 2; Mendel, I. 2; Raidot, J. P. 2; Kandel, G. 2; De Meuter, R. 3; Fabrigli, P. 4; Dehenau, D. 5; Arroyo, J. L. 6; Padron, F. 6; Gouezec, H. 7; Corral, M. 8; Jacquet, M. 9; Sundin, D. 9; Lin, L. 9; Corash, L. 9
[Article]
Vox Sanguinis.
94(4):315-323, May 2008.
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Background: An active haemovigilance programme was implemented to survey adverse events (AE) associated with transfusion of platelets photochemically treated with amotosalen and ultraviolet A (PCT-PLT). The results of 5106 transfusions have already been reported. Here we report the results of an additional 7437 PCT-PLT transfusions.
Methods: The focus of this ongoing haemovigilance programme is to document all AEs associated with PCT-PLT transfusion. Data collected for AEs include: time of event after starting transfusion, clinical descriptions, vital signs, results from radiographs and bacterial cultures, event severity (Grade 0-4) and causal relationship to PCT-PLT transfusion.
Results: One thousand four hundred patients (mean 60 years, range 1-96) received PCT-PLT transfusions. The majority of the patients (53[middle dot]4%) had haematology-oncology diseases and required conventional chemotherapy (44[middle dot]8%) or stem cell transplantation (8[middle dot]6%). Sixty-eight PCT-PLT transfusions were associated with AE. Acute transfusion reactions (ATR), classified as an AE possibly related, probably related, or related to PCT-PLT transfusions were infrequent (n = 55, 55/7437 = 0[middle dot]7%) and most were of Grade 1 severity. Thirty-nine patients (39/1400 = 2[middle dot]8%) experienced one or more ATRs. The most frequently reported signs/symptoms were chills, fever, urticaria, dyspnoea, nausea and vomiting. Five AEs were considered severe (>= Grade 2); however, no causal relationship to PCT-PLT transfusion was found. Repeated exposure to PCT-PLT did not increase the likelihood of an ATR. No cases of transfusion-related acute lung injury and no deaths due to PCT-PLT transfusions were reported.
Conclusions: Routine transfusion of PCT-PLT is well-tolerated in a wide range of patients. ATRs related to PCT-PLT transfusion were infrequent and most were of mild severity.
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