CAN TRASYLOL TREATMENT IN A REDUCED HAMME RSMITH DOSAGE WITH SIMULTANEOUS AUTOLOGOUS BLOOD-TRANSFUSION MEET THE DEMANDS OF OPEN-HEART-SURGERY

Problem: The general positive effect of the proteinase inhibitor trasy lol on blood loss and transfusion demand in cardiac surgery has been d emonstrated in several placebo-controlled studies. Given the possibili ty of cardiac and renal side effects associated with a high dose of tr asylol (Hammersmith dosage: 6 x 10(6) kallikrein inactivator units KIU ), the question of a dose reduction was raised. Methods: Being designe d as a randomized double-blind comparative group study, the investigat ion included 120 patients with elective primary cardiac surgery from N ovember 1990 to April 1992. One characteristic aspect of this study wa s the combined administration of trasylol and autologous blood transfu sions. To compare the efficacy and safety of different doses of trasyl ol, two groups, each with 60 patients, were created: the former with t he full Hammersmith dose (high dose group = HD group), the latter with half of the Hammersmith dose (los dose group = LD group). A placebo g roup had to be excluded for ethical reasons. Results: The trasylol pla sma levels showed a good dose correlation for the complete interval. T he intra-operative bleeding tendency, as judged by the surgeons in cha rge, did not show any statistical significant difference between the H D group and the LD group. As to the post-operative blood loss via thor acic drainage, the early collection periods did not show any differenc e between both study groups. Starting at 6 hours post-operatively, the drainage losses showed a tendency towards lower volumes in the HD gro up. This difference was statistically significant for the time period ''6-12 hours post-operatively''. The analysis of the post-operative co mplications did not show any difference. Summary: In this study with a high percentage of autologous blood transfusions, a lower dose of tra sylol seemed to be nearly as effective as a full Hammersmith dose. How ever, such a reduced dose did not demonstrate any advantage regarding the complication rate in comparison with the conventional high dose.