PMID- 29498049
OWN - NLM
STAT- MEDLINE
DCOM- 20181115
LR  - 20181115
IS  - 1537-2995 (Electronic)
IS  - 0041-1132 (Linking)
VI  - 58
IP  - 4
DP  - 2018 Apr
TI  - Red blood cells treated with the amustaline (S-303) pathogen reduction system: a 
      transfusion study in cardiac surgery.
PG  - 905-916
LID - 10.1111/trf.14528 [doi]
AB  - BACKGROUND: Nucleic acid-targeted pathogen inactivation technology using 
      amustaline (S-303) and glutathione (GSH) was developed to reduce the risk of 
      transfusion-transmitted infectious disease and transfusion-associated 
      graft-versus-host disease with red blood cell (RBC) transfusion. STUDY DESIGN AND 
      METHODS: A randomized, double-blind, controlled study was performed to assess the 
      in vitro characteristics of amustaline-treated RBCs (test) compared with 
      conventional (control) RBCs and to evaluate safety and efficacy of transfusion 
      during and after cardiac surgery. The primary device efficacy endpoint was the 
      postproduction hemoglobin (Hb) content of RBCs. Exploratory clinical outcomes 
      included renal and hepatic failure, the 6-minute walk test (a surrogate for 
      cardiopulmonary function), adverse events (AEs), and the immune response to 
      amustaline-treated RBCs. RESULTS: A total of 774 RBC unis were produced. Mean 
      treatment difference in Hb content was -2.27 g/unit (95% confidence interval, 
      -2.61 to -1.92 g/unit), within the prespecified equivalence margins (+/-5 g/unit) 
      to declare noninferiority. Amustaline-treated RBCs met European guidelines for Hb 
      content, hematocrit, and hemolysis. Fifty-one (25 test and 26 control) patients 
      received study RBCs. There were no significant differences in RBC usage or other 
      clinical outcomes. Observed AEs were within the spectrum expected for patients of 
      similar age undergoing cardiovascular surgery requiring RBCs transfusion. No 
      patients exhibited an immune response specific to amustaline-treated RBCs. 
      CONCLUSION: Amustaline-treated RBCs demonstrated equivalence to control RBCs for 
      Hb content, have appropriate characteristics for transfusion, and were well 
      tolerated when transfused in support of acute anemia. Renal impairment was 
      characterized as a potential efficacy endpoint for pivotal studies of RBC 
      transfusion in cardiac surgery.
CI  - (c) 2018 The Authors Transfusion published by Wiley Periodicals, Inc. on behalf of 
      AABB.
FAU - Brixner, Veronika
AU  - Brixner V
AUID- ORCID: 0000-0002-0686-1253
AD  - Institute for Transfusion Medicine and Immunohematology of Johann Wolfgang Goethe 
      University and German Red Cross Blood Donor Service, Frankfurt am Main, Germany.
FAU - Kiessling, Arndt-Holger
AU  - Kiessling AH
AD  - Department of Thoracic and Cardiovascular Surgery, Johann Wolfgang Goethe 
      University Hospital Frankfurt, Frankfurt am Main, Germany.
FAU - Madlener, Katharina
AU  - Madlener K
AD  - Department of Haemostaseology and Transfusion Medicine, Kerckhoff-Klinik, Bad 
      Nauheim, Germany.
FAU - Muller, Markus M
AU  - Muller MM
AD  - Institute for Transfusion Medicine and Immunohematology of Johann Wolfgang Goethe 
      University and German Red Cross Blood Donor Service, Frankfurt am Main, Germany.
FAU - Leibacher, Johannes
AU  - Leibacher J
AD  - Institute for Transfusion Medicine and Immunohematology of Johann Wolfgang Goethe 
      University and German Red Cross Blood Donor Service, Frankfurt am Main, Germany.
FAU - Dombos, Sarah
AU  - Dombos S
AD  - Institute for Transfusion Medicine and Immunohematology of Johann Wolfgang Goethe 
      University and German Red Cross Blood Donor Service, Frankfurt am Main, Germany.
FAU - Weber, Iuliia
AU  - Weber I
AD  - Institute for Transfusion Medicine and Immunohematology of Johann Wolfgang Goethe 
      University and German Red Cross Blood Donor Service, Frankfurt am Main, Germany.
FAU - Pfeiffer, Hans-Ulrich
AU  - Pfeiffer HU
AD  - Institute for Transfusion Medicine and Immunohematology of Johann Wolfgang Goethe 
      University and German Red Cross Blood Donor Service, Frankfurt am Main, Germany.
FAU - Geisen, Christof
AU  - Geisen C
AD  - Institute for Transfusion Medicine and Immunohematology of Johann Wolfgang Goethe 
      University and German Red Cross Blood Donor Service, Frankfurt am Main, Germany.
FAU - Schmidt, Michael
AU  - Schmidt M
AD  - Institute for Transfusion Medicine and Immunohematology of Johann Wolfgang Goethe 
      University and German Red Cross Blood Donor Service, Frankfurt am Main, Germany.
FAU - Henschler, Reinhard
AU  - Henschler R
AD  - Blood Center Zurich, Swiss Red Cross, Schlieren, Switzerland.
AD  - Red Cross Blood Service Graubunden, Chur, Switzerland.
FAU - North, Anne
AU  - North A
AD  - Cerus Corporation, Concord, California.
FAU - Huang, Norman
AU  - Huang N
AD  - Cerus Corporation, Concord, California.
FAU - Mufti, Nina
AU  - Mufti N
AD  - Cerus Corporation, Concord, California.
FAU - Erickson, Anna
AU  - Erickson A
AD  - Cerus Corporation, Concord, California.
FAU - Ernst, Christine
AU  - Ernst C
AD  - Cerus Corporation, Concord, California.
FAU - Rico, Salvador
AU  - Rico S
AD  - Cerus Corporation, Concord, California.
FAU - Benjamin, Richard J
AU  - Benjamin RJ
AD  - Cerus Corporation, Concord, California.
FAU - Corash, Laurence M
AU  - Corash LM
AD  - Cerus Corporation, Concord, California.
FAU - Seifried, Erhard
AU  - Seifried E
AD  - Institute for Transfusion Medicine and Immunohematology of Johann Wolfgang Goethe 
      University and German Red Cross Blood Donor Service, Frankfurt am Main, Germany.
LA  - eng
SI  - ClinicalTrials.gov/NCT01716923
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20180301
PL  - United States
TA  - Transfusion
JT  - Transfusion
JID - 0417360
RN  - 0 ((N,N-bis(2-chloroethyl))-2-aminoethyl-3-((acridin-9-yl)amino)propionate)
RN  - 0 (Acridines)
RN  - 0 (Hemoglobins)
RN  - 0 (Nitrogen Mustard Compounds)
RN  - GAN16C9B8O (Glutathione)
SB  - IM
MH  - Acridines/*pharmacology
MH  - Acute Kidney Injury/etiology
MH  - Aged
MH  - Aged, 80 and over
MH  - Bacteremia/*prevention & control/transmission
MH  - Blood Safety/*methods
MH  - *Blood-Borne Pathogens/drug effects
MH  - *Cardiac Surgical Procedures
MH  - Double-Blind Method
MH  - *Erythrocyte Transfusion/adverse effects
MH  - Erythrocytes/*drug effects
MH  - Female
MH  - Glutathione/pharmacology
MH  - Graft vs Host Disease/prevention & control
MH  - Heart Function Tests
MH  - Hemoglobins/analysis
MH  - Humans
MH  - Liver Failure/etiology
MH  - Male
MH  - Nitrogen Mustard Compounds/*pharmacology
MH  - Postoperative Complications/etiology
MH  - Transfusion Reaction/prevention & control
MH  - Viremia/*prevention & control/transmission
MH  - Virus Inactivation
EDAT- 2018/03/03 06:00
MHDA- 2018/11/16 06:00
CRDT- 2018/03/03 06:00
PHST- 2017/02/24 00:00 [received]
PHST- 2017/11/21 00:00 [revised]
PHST- 2017/11/21 00:00 [accepted]
PHST- 2018/03/03 06:00 [pubmed]
PHST- 2018/11/16 06:00 [medline]
PHST- 2018/03/03 06:00 [entrez]
AID - 10.1111/trf.14528 [doi]
PST - ppublish
SO  - Transfusion. 2018 Apr;58(4):905-916. doi: 10.1111/trf.14528. Epub 2018 Mar 1.