Reduced transfusion requirements by recombinant factor VIIa in orthotopic liver transplantation: a pilot study.
BACKGROUND
Large transfusion requirements, i.e., excessive blood loss, during orthotopic liver transplantation (OLT) are correlated with increased morbidity and mortality. Recombinant factor VIIa (rF-VIIa) has been shown to improve hemostasis in a variety of conditions, but has never been studied in liver transplantation.


METHODS
We performed a single-center, open-label, pilot study in adult patients undergoing OLT for cirrhosis Child-Pugh B or C, to assess efficacy and safety of rFVIIa. rFVIIa (80 microg/kg) was administered at the start of the operation, to be repeated according to predefined criteria. Packed red blood cells (RBC), fresh-frozen plasma, and platelet concentrates were administered according to predefined criteria. Perioperative transfusion requirements in study patients were compared with matched controls.


RESULTS
Six patients were enrolled in the study. All received a single dose of rFVIIa. Transfusion requirements (given as median, with range in parentheses) were lower in the study group than in matched controls: 1.5 (0-5) vs. 7 (2-18) units of allogeneic RBC (P=0.006), 0 (0-2) vs. 3.5 (0-23) units of autologous RBC (P=0.043), total amount of RBC 3 (0-5) vs. 9 (4-40) units (P=0.002). Transfused fresh-frozen plasma was 1 (0-7) vs. 8 (2-35) units (P=0.011). Blood loss was 3.5 L (1.4-5.3) vs. 9.8 L (3.7-35.0) (P=0.004). One study patient developed a hepatic artery thrombosis at day 1 postoperatively.


CONCLUSIONS
A single dose of 80 microg/kg rFVIIa significantly reduced transfusion requirements during OLT. Further study is needed to establish the optimally effective and safe dose of rFVIIa in orthotopic liver transplantation.
Hendriks
H G
HG
Department of Anaesthesiology, and Trial Coordination Centre, University Hospital Groningen, The Netherlands.
Meijer
K
K
de Wolf
J T
JT
Klompmaker
I J
IJ
Porte
R J
RJ
de Kam
P J
PJ
Hagenaars
A J
AJ
Melsen
T
T
Slooff
M J
MJ
van der Meer
J
J
D000328:Adult; D016063:Blood Loss, Surgical / Q000517:prevention & control*; D001803:Blood Transfusion; D015942:Factor VIIa / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D016031:Liver Transplantation; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011994:Recombinant Proteins / Q000627:therapeutic use
D011994:Recombinant Proteins; D015942:Factor VIIa