Aprotinin and transfusion requirements in orthotopic liver transplantation: a multicentre randomised double-blind study. EMSALT Study Group.
BACKGROUND
Intraoperative hyperfibrinolysis contributes to bleeding during adult orthotopic liver transplantation. We aimed to find out whether aprotinin, a potent antifibrinolytic agent, reduces blood loss and transfusion requirements.


METHODS
We did a randomised, double-blind, placebo-controlled trial in which six liver-transplant centres participated. Patients undergoing primary liver transplantation were randomly assigned intraoperative high-dose aprotinin, regular-dose aprotinin, or placebo. Primary endpoints were intraoperative blood loss and transfusion requirements. Secondary endpoints were perioperative fluid requirements, postoperative blood transfusions, complications, and mortality.


RESULTS
137 patients received high-dose aprotinin (n=46), regular-dose aprotinin (n=43), or placebo (n=48). Intraoperative blood loss was significantly lower in the aprotinin-treated patients, with a reduction of 60% in the high-dose group and 44% in the regular-dose group, compared with the placebo group (p=0.03). Total amount of red blood cell (homologous and autologous) transfusion requirements was 37% lower in the high-dose group and 20% lower in the regular-dose group, than in the placebo group (p=0.02). Thromboembolic events occurred in two patients in the high-dose group, none in the regular-dose group, and in two patients in the placebo group (p=0.39). Mortality at 30 days did not differ between the three groups (6.5%, 4.7%, and 8.3%; p=0.79).


CONCLUSIONS
Intraoperative use of aprotinin in adult patients undergoing orthotopic liver transplantation significantly reduces blood-transfusion requirements and should be routinely used in patients without contraindications.
Porte
R J
RJ
Department of Surgery, Leiden University Medical Centre, The Netherlands. r.j.porte@chir.azg.nl
Molenaar
I Q
IQ
Begliomini
B
B
Groenland
T H
TH
Januszkiewicz
A
A
Lindgren
L
L
Palareti
G
G
Hermans
J
J
Terpstra
O T
OT
D000293:Adolescent; D000328:Adult; D000368:Aged; D007611:Aprotinin / Q000008:administration & dosage* / Q000009:adverse effects; D016063:Blood Loss, Surgical / Q000503:physiopathology; D001803:Blood Transfusion; D002423:Cause of Death; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005342:Fibrinolysis / Q000187:drug effects; D006490:Hemostatics / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D007262:Infusions, Intravenous; D016031:Liver Transplantation; D008297:Male; D008875:Middle Aged; D019106:Postoperative Hemorrhage / Q000188:drug therapy / Q000401:mortality; D015996:Survival Rate
D006490:Hemostatics; D007611:Aprotinin