Systematic use of aprotinin in cardiac surgery: influence on total homologous exposure and hospital cost.

To assess the impact of systematic use of aprotinin, 115 consecutive adults undergoing cardiac surgery were randomly allocated with a sealed envelope technique. Treated (T) patients (n = 58) received 2.10(6) Kallikrein Inactivating Units (KIU) before incision, 2.10(6) prior to bypass, and 5.10(5) KIU.hr-1 for 5 hrs, whereas control (C) cases (n = 57) received nothing. Surgeons, perfusionists, ICU and ward physicians were blinded. Postoperative blood loss decreased from 1198 ml (C) to 698 ml (T) (p less than 0.001). Total transfusional needs were 7.25 (C) and 4.9 (T) units (p less than 0.01), where from 65% were autologous in group T, versus 51% in group C (p less than 0.02). Total homologous exposure decreased from 4.5 (C) to 2.7 (T) units on the average, from 3 to 1 units as a median (p less than 0.01). Multiple Stepwise Regression Analysis showed treatment as the most important variable influencing postoperative blood loss, but duration and type of procedures were more important to explain transfusion needs. Both groups were comparable for other pre- and intra-operative variables. For coronary operations (n = 75), aprotinin showed the strongest negative association with blood loss, the number of arterial conduits being the second influencing variable. No evidence was found for increased early graft thrombosis. The average hospital bill was 9% lower in the treated group, an unexplained finding needing independent confirmation.

RCT Entities:   Population Interventions Outcomes