Recombinant activated factor VII (rFVIIa) acutely normalizes prothrombin time in patients with cirrhosis during bleeding from oesophageal varices.
BACKGROUND
Patients with cirrhosis have low levels of coagulation factors, the most pronounced deficiency being that of FVII. This may compromise haemostasis during bleeding from ruptured oesophageal varices. The objective of this trial was to evaluate the effect of rFVIIa on prothrombin time in cirrhosis patients with ongoing variceal bleeding. Safety, including signs of DIC, was monitored.


METHODS
The study is a single centre, open-label trial. Ten consecutive patients with known alcoholic cirrhosis and oesophageal variceal bleeding were included. The patients received routine treatment, including Terlipressin. Each patient received one i.v. injection of rFVIIa (80 microg/kg bw). The study observation time was 12 h per patient.


RESULTS
The mean age of the patients was 48 years (8 men and 2 women). The cirrhosis was classified as Child B in 5 patients and Child C in 5. At baseline, all patients had prothrombin time levels above the normal range, and all but one had FVII coagulation activity (FVII:C) levels below the normal range. rFVIIa normalized the prothrombin time in all patients within 30 min. The effect lasted for more than 4 h in 7 patients, and for about 2 h in the remaining 3 patients. Immediate bleeding control was obtained in all patients, and no patient died within the study time. There was no sign of DIC.


CONCLUSIONS
rFVIIa is effective in transiently reversing the prolonged prothrombin time in cirrhosis patients with haematemesis from varices. This indicates a potential of improving haemostasis and survival in patients with compromised coagulation due to liver disease.
Ejlersen
E
E
Dept. of Medicine V and Centre for Haemophilia and Thrombosis, Aarhus University Hospital, Denmark.
Melsen
T
T
Ingerslev
J
J
Andreasen
R B
RB
Vilstrup
H
H
D000328:Adult; D000368:Aged; D004932:Esophageal and Gastric Varices / Q000097:blood* / Q000209:etiology / Q000628:therapy; D005260:Female; D006471:Gastrointestinal Hemorrhage / Q000097:blood* / Q000209:etiology / Q000628:therapy; D006487:Hemostasis / Q000187:drug effects; D006801:Humans; D007275:Injections, Intravenous; D008104:Liver Cirrhosis, Alcoholic / Q000097:blood* / Q000150:complications; D008236:Lypressin / Q000031:analogs & derivatives* / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D011517:Prothrombin Time; D011994:Recombinant Proteins / Q000627:therapeutic use*; D000077585:Terlipressin; D014662:Vasoconstrictor Agents / Q000627:therapeutic use
D011994:Recombinant Proteins; D014662:Vasoconstrictor Agents; D008236:Lypressin; D000077585:Terlipressin