Safety and hemostatic effect of recombinant activated factor VII in cirrhotic patients undergoing partial hepatectomy: a multicenter, randomized, double-blind, placebo-controlled trial.
BACKGROUND
Coagulopathy caused by cirrhosis may contribute to excessive bleeding during hepatectomy. We evaluated the hemostatic effect and safety of recombinant factor VIIa (rFVIIa) in cirrhotic patients undergoing partial hepatectomy.


METHODS
Patients were randomized to rFVIIa 50 or 100 mug/kg or placebo, administered intravenously 10 minutes before surgery and every second hour during surgery. The primary efficacy end points were the proportion of patients receiving red blood cell (RBC) transfusions and the amount of RBCs transfused. The RBC transfusion trigger was blood loss of 500 mL. Safety end points included thromboembolic and adverse events.


RESULTS
No statistically significant effect of rFVIIa treatment on efficacy end points was observed. Serious and thromboembolic adverse events occurred at similar incidences in the study groups.


CONCLUSIONS
Using blood loss as a transfusion trigger, the efficacy of rFVIIa in reducing the requirement for RBC transfusion was not established in this study. No safety concerns were identified.
Shao
Yong-Fu
YF
Department of Abdominal Surgery, Tumor Hospital of Chinese Academy of Medical Sciences, Beijing, China.
Yang
Jia-Mei
JM
Chau
Gar-Yang
GY
Sirivatanauksorn
Yongyut
Y
Zhong
Shou-Xian
SX
Erhardtsen
Elisabeth
E
Nivatvongs
Supanit
S
Lee
Po-Huang
PH
D000328:Adult; D000368:Aged; D004311:Double-Blind Method; D017707:Erythrocyte Transfusion; D015942:Factor VIIa / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006489:Hemostatic Techniques; D006498:Hepatectomy; D006801:Humans; D008103:Liver Cirrhosis / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D012449:Safety
D011994:Recombinant Proteins; D015942:Factor VIIa