Australian Public Assessment

Report for Tranexamic acid

• The safety summary referred to all adverse events occurring in the
cardiac surgery studies as serious.
• Adverse events occurred in a greater percentage of patients treated with
the three active treatments compared with control with the risk being
about 2.4 fold greater with TXA than with control.
• in high risk procedures adverse events occurred in a greater percentage
of patients in each of the three active treatment groups compared with
non-active control. In high risk procedures the risk of patients
experiencing an adverse event was about 3.1 fold greater with TXA than
with non-active control
• the most commonly occurring adverse events reported with TXA were
renal (7.5% versus 0.8% in non-active control patients).
 INCLUSION & EXCLUSION
• Dalam studi ini semua pasien menjalani salah satu dari berikut
elektif atau risiko tinggi yang mendesak prosedur bedah jantung
pada CPB: ulangi bedah jantung; terisolasi penggantian katup
mitral; katup gabungan dan operasi CABG; beberapa
penggantian katup atau perbaikan; dan pembedahan aorta
menaik atau lengkungan Aortik.
• Penelitian ini mengecualikan pasien yang menjalani operasi
berisiko rendah seperti CABG utama terisolasi dengan atau
tanpa CPB, mengisolasi katup mitral-perbaikan atau prosedur
penggantian aorticvalve dan jarang seperti transplantasi jantung,
implantasi dari perangkat bantuan ventrikel kiri dan
pembedahan untuk memperbaiki cacat jantung bawaan.
 Death

• The overall mortality rate in TXA treated patients was 1.7%

(64/3852) which compared with 1.8% (22/1247) in non-
active control patients.
• The most common cause of death was due to cardiac or
cardiac related causes (for example, multi-organ failure due
to low cardiac output).
• The "other" reported causes of death included wound
infection, haemorrhage and multi-organ failure.
• The risk differences were not statistically significant for any
of the comparisons.