Objective: Recently, the safety of aprotinin administration during open-heart surgery has been debated. The aim of the study was to compare the blood sparing effect and the side effects of aprotinin and tranexamic acid in paediatric cardiac surgery patients.
Methods: Perioperative data of 199 consecutive patients weighing less than 20kg undergoing open-heart cardiac surgery were prospectively collected between September 2005 and June 2006. During the first 5 months, 85 patients received aprotinin (group A); in the next 5 months, 114 patients were treated with tranexamic acid (group T). Except for antifibrinolytic therapy, the anaesthesiological and surgical protocols remained unchanged. Postoperative complications and in-hospital and 1-year mortality were considered as outcome parameters.
Results: The descriptive parameters and the intraoperative parameters were well comparable in the two groups. The blood loss was significantly lower in group A compared to group T at 6h [55 (35-82.5) vs 70 (45-100)ml, p=0.031], but not at 12 and 24h after operation. The incidence [9 (11%) vs 25 (22%), p=0.035] and the amount of red blood cell transfusion during the first 24h after surgery were also significantly lower in group A (0.1+/-0.4 vs 0.3+/-0.6 unit, p=0.036). There were significantly less rethoracotomies in group A [2 (2.4%) vs 11 (9.6%), p=0.039]. We found no difference in the incidence of the postoperative complications and in-hospital and 1-year mortality. There was a tendency for a higher incidence of seizures in group T [4 (3.5%) vs 0 (0%), p=0.14].
Conclusions: Aprotinin administration bears no additional risks compared to tranexamic acid and it has a stronger blood sparing effect in paediatric cardiac surgery. There were fewer rethoracotomies and less postoperative red blood cell transfusion in patients who received aprotinin.