- hemostatic agent which regulates the following:
- regulates fibrinolysis
- intrinsic coagulation pathway
- stabilizes platelet function
- exhibits anti-inflammatory properties through inhibition of serine proteases;
- in the report by JM Murkin MD et al (JBJS May 2000, Vol 82-A, No 5 Page 675), the authors performed a multicenter,
randomized, placebo-controlled, double-blind trial were to evaluate the efficacy and safety of aprotinin as a
blood-sparing agent in patients undergoing an elective primary unilateral total hip replacement and to examine
its effect on the prevalence of deep-vein thrombosis in this population.
- 73 patients received a placebo; 76 patients, a low dose of aprotinin (a load
of 500,000 kallikrein inhibitor units [KIU]); 75, a medium dose of aprotinin
(a load of 1,000,000 KIU, with infusion of 250,000 KIU per hour); and 77 patients,
a high dose of aprotinin (a load of 2,000,000 KIU, with infusion of 500,000 KIU per hour);
- end points for the determination of efficacy were transfusion requirements and blood loss.
- aprotinin reduced the percentages of patients who required any form of blood transfusion (47
percent of the patients managed with a placebo needed a transfusion compared with 28 percent of those
managed with low-dose aprotinin [p = 0.02], 27 percent of those managed with high-dose aprotinin [p =
0.008], and 40 percent of those managed with medium-dose aprotinin [p = 0.5]). Only 6 percent (twelve)
- of the 212 patients treated with aprotinin required allogeneic blood compared with 15 percent (ten) of the
sixty-eight patients treated with the placebo (p = 0.03).
- aprotinin decreased the estimated intraoperative blood loss (p = 0.02 for the low-dose group, p = 0.04 for
the medium-dose group, and p = 0.1 for the high-dose group), the measured postoperative drainage volume
(p = 0.4 for the low-dose group, p = 0.006 for the medium-dose group, and p = 0.000 for the high-dose group),
and the mean reduction in the hemoglobin level on the second postoperative day (thirty-four grams per liter
for the placebo group, twenty-eight grams per liter for the low-dose group [p = 0.000], twenty-six grams per
liter for the medium-dose group [p = 0.000], and twenty-three grams per liter for the high-dose group [p = 0.000]).
- rate of deep-vein thrombosis was similar for all groups.