Aprotinin, that is a question
" The former use of aprotinin affected the concepts of heparinization
for CPB for intracardiac surgery, because this agent
prolongs both clotting time and ACT, depending on the
method of measurement. If aprotinin is used, an optimal recommendation
is to administer the usual initial dose of heparin
and add additional heparin to maintain the ACT above 700
seconds if the activating agent is Celite (diatomaceous earth).
Kaolin is a more dependable activating agent, giving ACTs
in the presence of aprotinin similar to those without aprotinin
in vitro and during CPB. Therefore, a preferable method
when aprotinin is used during CPB is to use kaolin as the
activating agent and maintain the usual ACT at 480 seconds.
Alternatively, the heparin concentration is measured at intervals
and kept above 3 mg · kg−1. Because of results of randomized
trials demonstrating that aprotinin was associated with a
higher risk of death after cardiac surgical procedures than
other antifibrinolytic agents used to decrease the need for red
blood cell transfusions,Bayer Pharmaceuticals withdrew
their drug Trasylol (aprotinin) from the market in May 2008.
Subsequent meta-analysis has confirmed higher morbidity
and mortality associated with use of aprotinin."
(Kirklin)
BUT
http://bja.oxfordjournals.org/content/110/5/675.full
Conclusion
"Clearly, aprotinin effectively reduces blood loss and the need for transfusion associated with heart surgery and currently in Canada and the EU, Health Canada, and the EMA believe the accumulated evidence of the benefits of aprotinin outweigh its risks in isolated CABG surgery.21,22 In other countries such as the USA, aprotinin may never be used again even if its licence is fully reinstated because manufacturers may decide that the product liability is too high. So, a drug that has great patient benefits will remain unavailable to many patients around the world because of evidence from weak observational studies and the flawed evidence of one published RCT that undermined confidence in the drug's safety. Evidence is essential to drive medicine forward into the future, but we need to remain careful as to how it is created and vigilant to how it is evaluated, published, and interpreted."
for CPB for intracardiac surgery, because this agent
prolongs both clotting time and ACT, depending on the
method of measurement. If aprotinin is used, an optimal recommendation
is to administer the usual initial dose of heparin
and add additional heparin to maintain the ACT above 700
seconds if the activating agent is Celite (diatomaceous earth).
Kaolin is a more dependable activating agent, giving ACTs
in the presence of aprotinin similar to those without aprotinin
in vitro and during CPB. Therefore, a preferable method
when aprotinin is used during CPB is to use kaolin as the
activating agent and maintain the usual ACT at 480 seconds.
Alternatively, the heparin concentration is measured at intervals
and kept above 3 mg · kg−1. Because of results of randomized
trials demonstrating that aprotinin was associated with a
higher risk of death after cardiac surgical procedures than
other antifibrinolytic agents used to decrease the need for red
blood cell transfusions,Bayer Pharmaceuticals withdrew
their drug Trasylol (aprotinin) from the market in May 2008.
Subsequent meta-analysis has confirmed higher morbidity
and mortality associated with use of aprotinin."
(Kirklin)
BUT
http://bja.oxfordjournals.org/content/110/5/675.full
Conclusion
"Clearly, aprotinin effectively reduces blood loss and the need for transfusion associated with heart surgery and currently in Canada and the EU, Health Canada, and the EMA believe the accumulated evidence of the benefits of aprotinin outweigh its risks in isolated CABG surgery.21,22 In other countries such as the USA, aprotinin may never be used again even if its licence is fully reinstated because manufacturers may decide that the product liability is too high. So, a drug that has great patient benefits will remain unavailable to many patients around the world because of evidence from weak observational studies and the flawed evidence of one published RCT that undermined confidence in the drug's safety. Evidence is essential to drive medicine forward into the future, but we need to remain careful as to how it is created and vigilant to how it is evaluated, published, and interpreted."
