PMID- 23294315
OWN - NLM
STAT- MEDLINE
DCOM- 20140214
LR  - 20130422
IS  - 1423-0410 (Electronic)
IS  - 0042-9007 (Linking)
VI  - 104
IP  - 4
DP  - 2013 May
TI  - A regional haemovigilance retrospective study of four types of therapeutic plasma 
      in a ten-year survey period in France.
PG  - 337-41
LID - 10.1111/vox.12007 [doi]
AB  - BACKGROUND AND OBJECTIVES: Our objective was to compare the frequency of adverse 
      events (AEs) due to any of the 4 types of fresh-frozen plasma (FFP) prepared and 
      delivered by the French Blood Establishment (EFS) over a 10-year period. 
      Surveillance of AEs and vigilance was performed according to a homogeneous 
      policy. The four types of FFP comprised of one type (methylene blue [MB) that was 
      stopped since then and of another type [amotosalen (AI)] that was recently 
      introduced, along with two conventional products [quarantine (Q) and 
      solvent-detergent (SD)]. MATERIALS AND METHODS: This is a retrospective study 
      based on the national AE reporting database and on the regional database system 
      for deliveries. AEs recorded after the delivery of 1 of the 4 types of FFP were 
      pairwise compared, with appropriate statistical corrections. RESULTS: 105,964 FFP 
      units were delivered (38.4% Q, 17.9% SD, 9.7% MB and 34% AI). Statistical 
      comparisons of AEs identified only a difference in AE rates between quarantine 
      and solvent-detergent plasma. CONCLUSIONS: FFP was confirmed to be extremely safe 
      in general, especially if one considers 'severe' AEs. All types of FFP were 
      associated with extremely low occurrences of AEs. Q, SD, MB and AI led, 
      respectively, to 7.14, 4.86, 1.05 and 4.16 AEs per 10,000 deliveries.
CI  - (c) 2013 The Author(s). Vox Sanguinis (c) 2013 International Society of Blood 
      Transfusion.
FAU - Bost, V
AU  - Bost V
AD  - Etablissement Francais du Sang-Auvergne - Loire, Saint-Etienne, France.
FAU - Odent-Malaure, H
AU  - Odent-Malaure H
FAU - Chavarin, P
AU  - Chavarin P
FAU - Benamara, H
AU  - Benamara H
FAU - Fabrigli, P
AU  - Fabrigli P
FAU - Garraud, O
AU  - Garraud O
LA  - eng
PT  - Journal Article
DEP - 20130107
PL  - England
TA  - Vox Sang
JT  - Vox sanguinis
JID - 0413606
SB  - IM
MH  - Blood Safety/instrumentation/*methods
MH  - Blood Transfusion/*standards
MH  - Data Collection
MH  - France
MH  - Humans
MH  - Plasma/*chemistry
MH  - Retrospective Studies
EDAT- 2013/01/09 06:00
MHDA- 2014/02/15 06:00
CRDT- 2013/01/09 06:00
PHST- 2012/07/24 00:00 [received]
PHST- 2012/11/10 00:00 [revised]
PHST- 2012/11/19 00:00 [accepted]
PHST- 2013/01/09 06:00 [entrez]
PHST- 2013/01/09 06:00 [pubmed]
PHST- 2014/02/15 06:00 [medline]
AID - 10.1111/vox.12007 [doi]
PST - ppublish
SO  - Vox Sang. 2013 May;104(4):337-41. doi: 10.1111/vox.12007. Epub 2013 Jan 7.