PMID- 27001358
OWN - NLM
STAT- MEDLINE
DCOM- 20160801
LR  - 20160322
IS  - 1537-2995 (Electronic)
IS  - 0041-1132 (Linking)
VI  - 56 Suppl 1
DP  - 2016 Mar
TI  - The role of hemovigilance and postmarketing studies when introducing innovation 
      into transfusion medicine practice: the amotosalen-ultraviolet A pathogen 
      reduction treatment model.
PG  - S29-38
LID - 10.1111/trf.13530 [doi]
AB  - BACKGROUND: Innovations in transfusion medicine require randomized controlled 
      clinical trials (RCTs) to demonstrate safety and efficacy before approval; 
      however, these studies are costly and limited in scope and may be underpowered to 
      detect rare adverse events (AEs). Regulatory agencies, such as the Food and Drug 
      Administration, require postmarketing surveillance, hemovigilance (HV), and 
      controlled Phase IV studies to monitor performance and confirm safety. STUDY 
      DESIGN AND METHODS: The INTERCEPT Blood System (IBS) is an illustrative model for 
      implementation of a transformative technology for which sponsored active HV, 
      regulatory authority HV, and Phase IV studies were used to extend preapproval 
      efficacy and safety information. RESULTS: After CE mark registration in Europe, 
      13,644 patients received 76,346 IBS components prepared largely without gamma 
      irradiation or bacterial screening in sponsored active HV studies documenting no 
      increased incidence of AEs compared to historical controls and no increased 
      component utilization. National HV systems in France and Switzerland specifically 
      demonstrated no transfusion-associated graft-versus-host disease or increased 
      incidence of transfusion-associated acute lung injury, after transfusion of 
      317,669 IBS platelet (PLT) components, and significant reduction of 
      transfusion-transmitted bacterial infection as well as acute transfusion 
      reactions. Cumulatively, these studies provide new information about safety and 
      efficacy of IBS PLT and plasma components not obtainable from RCTs. CONCLUSION: 
      Although inherently different from RCTs, properly designed postmarketing studies 
      are informative regarding the safety and efficacy of innovative transfusion 
      technologies in large patient populations under conditions of routine use.
CI  - (c) 2016 AABB.
FAU - Corash, Laurence
AU  - Corash L
AD  - Cerus Corporation, Concord, California.
FAU - Benjamin, Richard J
AU  - Benjamin RJ
AD  - Cerus Corporation, Concord, California.
LA  - eng
PT  - Journal Article
PT  - Review
PL  - United States
TA  - Transfusion
JT  - Transfusion
JID - 0417360
RN  - 0 (Furocoumarins)
RN  - K1LDZ0VBC0 (amotosalen)
SB  - IM
MH  - Blood Safety/*methods
MH  - Disinfection/*methods
MH  - Furocoumarins/*chemistry
MH  - Humans
MH  - *Models, Theoretical
MH  - *Product Surveillance, Postmarketing
MH  - *Ultraviolet Rays
EDAT- 2016/03/24 06:00
MHDA- 2016/08/02 06:00
CRDT- 2016/03/23 06:00
PHST- 2016/03/23 06:00 [entrez]
PHST- 2016/03/24 06:00 [pubmed]
PHST- 2016/08/02 06:00 [medline]
AID - 10.1111/trf.13530 [doi]
PST - ppublish
SO  - Transfusion. 2016 Mar;56 Suppl 1:S29-38. doi: 10.1111/trf.13530.