Safety and efficacy of recombinant factor VIIa in patients with liver disease undergoing laparoscopic liver biopsy.
OBJECTIVE
Activated recombinant factor VII (rFVIIa) has been shown to be effective in correcting prolonged prothrombin time (PT) in cirrhotic patients. The main objective of this study was to evaluate the effect of 4 (5, 20, 80, and 120 microg/kg) doses of rFVIIa on correction of PT and the time to achieve hemostasis in cirrhotic patients with coagulopathy who are undergoing laparoscopic liver biopsy.


METHODS
Seventy-one patients (parts I and II) with advanced liver disease (Child-Turcotte B or C), platelet count > or =60,000/mm3, and PT in the range of 3-15 seconds above normal were included in the study. Efficacy endpoints were normalization of PT and time to hemostasis.


RESULTS
PT was corrected to normal levels (<13.1 seconds) in the majority of patients. The duration of normalization of PT was longer in patients treated with higher doses of rFVIIa. Forty-eight (74%) of 65 patients (part II) achieved hemostasis within 10 minutes. No correlation between the time to hemostasis and duration of correction of PT was observed. None of the patients required operative intervention or transfusion of blood/blood products to control bleeding. One thrombotic event and one case of disseminated intravascular coagulation were reported, but both events were considered by the investigator as unlikely to be related to treatment with rFVIIa.


CONCLUSIONS
The results of this study suggest that treatment with rFVIIa may offer benefit for patients with liver disease undergoing laparoscopic biopsy.
Jeffers
Lennox
L
Center for Liver Disease, University of Miami School of Medicine, Miami, Florida 33125, USA. l.jeffers@miami.edu
Chalasani
Naga
N
Balart
Luis
L
Pyrsopoulos
Nikolaos
N
Erhardtsen
Elisabeth
E
D000328:Adult; D001706:Biopsy; D001778:Blood Coagulation Disorders / Q000188:drug therapy* / Q000209:etiology* / Q000503:physiopathology; D004311:Double-Blind Method; D015942:Factor VIIa / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006487:Hemostasis; D006801:Humans; D010535:Laparoscopy; D008099:Liver / Q000473:pathology*; D008107:Liver Diseases / Q000150:complications* / Q000473:pathology*; D008297:Male; D008875:Middle Aged; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use; D012449:Safety; D013997:Time Factors
D011994:Recombinant Proteins; D015942:Factor VIIa