PMID- 24977631
OWN - NLM
STAT- MEDLINE
DCOM- 20141121
LR  - 20210902
IS  - 1526-7598 (Electronic)
IS  - 0003-2999 (Linking)
VI  - 119
IP  - 4
DP  - 2014 Oct
TI  - A safety and efficacy evaluation of hemoglobin-based oxygen carrier HBOC-201 in a 
      randomized, multicenter red blood cell controlled trial in noncardiac surgery 
      patients.
PG  - 766-776
LID - 10.1213/ANE.0000000000000305 [doi]
AB  - BACKGROUND: We present the results of a previously unpublished hemoglobin-based 
      oxygen carrier (HBOC) study conducted in 1998-1999. METHODS: In a multicenter, 
      randomized, single-blind, comparative study of HBOC-201 versus allogeneic red 
      blood cell (RBC) transfusions, no-cardiac surgery patients received HBOC-201 to a 
      maximum of 7 units (n = 83) or RBCs (n = 77). Patients could be switched to RBCs 
      for safety or any other reason. The efficacy end points were elimination and/or 
      reduction of allogeneic RBC transfusions for 28 days. RESULTS: The proportion of 
      patients in the HBOC-201 group that avoided RBC transfusion was 0.427 (95% 
      confidence interval, 0.321-0.533). Subjects in the HBOC-201 group received on 
      average 3.2 units of RBCs versus 4.4 units in the control arm (P = 0.004). 
      Seventy-nine (95.2%) subjects in the HBOC-201 group and 72 (93.5%) in the RBC 
      group experienced adverse events (AEs), judged to be associated with study 
      treatment in 59 (71.1%) and 18 (23.4%) subjects, respectively. Thirty-day 
      mortality, 5 (6.0%) vs 4 (5.2%) patients (P = 1.00), incidence of serious AEs, 24 
      (28.9%) vs 20 (26.0%) (P = 0.73), or time to intensive care unit (log-rank P = 
      0.15) or hospital discharge (log-rank P = 0.53) were similar for the HBOC-201 and 
      RBC groups, respectively. CONCLUSIONS: Up to 7 units of HBOC-201 infused over the 
      course of 6 days resulted in RBC transfusion avoidance in 43% of patients. There 
      were no notable differences in mortality and serious AEs incidence. The use of 
      HBOC-201 was associated with a notable excess of nonserious AEs.
FAU - Van Hemelrijck, Jan
AU  - Van Hemelrijck J
AD  - From the Department of Anesthesiology, Universitaire Ziekenhuizen Katholieke 
      Universiteit Leuven, Leuven, Belgium; Department of Vascular Surgery, Milpark 
      Hospital, Parktown, Johannesburg, South Africa; Independent Biostatistics 
      Consultant, Peabody, Massachusetts; Independent Consultant, Needham, 
      Massachusetts; Department of Anesthesiology, University Hospital, Eppendorf, 
      Hamburg, Germany.
FAU - Levien, Lewis J
AU  - Levien LJ
FAU - Veeckman, Luc
AU  - Veeckman L
FAU - Pitman, Arkadiy
AU  - Pitman A
FAU - Zafirelis, Zafiris
AU  - Zafirelis Z
FAU - Standl, Thomas
AU  - Standl T
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Anesth Analg
JT  - Anesthesia and analgesia
JID - 1310650
RN  - 0 (Blood Substitutes)
RN  - 0 (Hemoglobins)
RN  - 1XQE66T19H (HBOC 201)
SB  - IM
CIN - Anesth Analg. 2014 Oct;119(4):758-60. PMID: 25232689
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Blood Substitutes/*administration & dosage/*adverse effects
MH  - Drug Evaluation/methods
MH  - Erythrocyte Transfusion/*adverse effects/methods
MH  - Female
MH  - Fever/chemically induced/diagnosis
MH  - Follow-Up Studies
MH  - Hemoglobins/*administration & dosage/*adverse effects
MH  - Humans
MH  - Hypertension/chemically induced/diagnosis
MH  - Male
MH  - Middle Aged
MH  - Perioperative Care/adverse effects/*methods
MH  - Single-Blind Method
MH  - Treatment Outcome
MH  - Young Adult
EDAT- 2014/07/01 06:00
MHDA- 2014/12/15 06:00
CRDT- 2014/07/01 06:00
PHST- 2014/07/01 06:00 [entrez]
PHST- 2014/07/01 06:00 [pubmed]
PHST- 2014/12/15 06:00 [medline]
AID - 00000539-201410000-00004 [pii]
AID - 10.1213/ANE.0000000000000305 [doi]
PST - ppublish
SO  - Anesth Analg. 2014 Oct;119(4):766-776. doi: 10.1213/ANE.0000000000000305.