Safety and efficacy of recombinant factor VIIa in patients with liver disease undergoing laparoscopic liver biopsy

Lennox J Jeffers, Naga Chalasani, Luis Balart, Nikolaos Pyrsopoulos, Elisabeth Erhardtsen

Research output: Contribution to journalArticle

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Abstract

Background & Aims: 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 μg/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 ≥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.

Original languageEnglish
Pages (from-to)118-126
Number of pages9
JournalGastroenterology
Volume123
Issue number1
DOIs
StatePublished - Jul 20 2002

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Prothrombin Time
Liver Diseases
Biopsy
Safety
Liver
Hemostasis
Factor VIIa
recombinant FVIIa
Disseminated Intravascular Coagulation
Platelet Count
Blood Transfusion
Research Personnel
Hemorrhage
Therapeutics

ASJC Scopus subject areas

  • Gastroenterology

Cite this

Safety and efficacy of recombinant factor VIIa in patients with liver disease undergoing laparoscopic liver biopsy. / Jeffers, Lennox J; Chalasani, Naga; Balart, Luis; Pyrsopoulos, Nikolaos; Erhardtsen, Elisabeth.

In: Gastroenterology, Vol. 123, No. 1, 20.07.2002, p. 118-126.

Research output: Contribution to journalArticle

Jeffers, Lennox J ; Chalasani, Naga ; Balart, Luis ; Pyrsopoulos, Nikolaos ; Erhardtsen, Elisabeth. / Safety and efficacy of recombinant factor VIIa in patients with liver disease undergoing laparoscopic liver biopsy. In: Gastroenterology. 2002 ; Vol. 123, No. 1. pp. 118-126.
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