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Aprotinin

An antifibrinolytic agent that can reduce perioperative blood loss from cardiac or major orthopedic surgery.

A serine protease inhibitor that neutralizes plasmin.

A known inhibitor of aPC, inducing resistance to aPC in normal plasma and exacerbates aPC resistance further in the plasma from Factor V Leiden heterozygotes.

Use associated with higher mortality rate than patients who received aminocaproic acid alone, with a 64% increase in mortality (4.5% v. 2.5.%).

Observational studies associated with increased risk of renal failure, myocardial infarction, strokes and death when used in cardiac surgery, but meta-analysis showed no increased risks of these processes (Ray).

Blood Conservation Using Antifibrinolytics in a Randomized Trial (BART) compared aprotinin with lysine analogues aminocaproic acid and tranexamic high risk cardiac surgery: modest evidence that aprotinin was the more effective hemostatic agent reducing risk of massive postoperative bleeding by a borderline statistical significance.

BART study revealed aprotinin use reduced need for post surgical blood products.

BART study revealed at 30 days aprotinin treated patients had an increased risk of death of more than 50%.

Meta-analyses prior to the BART study revealed no evidence of increased risk of death.

A meta-analysis of head-to-head trials of aprotinin versus aminocaproic acid resulted in .20 fewer unit of blood transfused per patient with no reduction in mortality. (Henry, DA)

There is greater frequency of revascularization procedures in dialysis among aprotinin recipients than among aminocaproic acid recipients suggesting that there may be more frequent hypercoagulable problems with aprotinin. (Schneeweiss, S)

An analysis of patients undergoing coronary artery bypass with 33,000 patients receiving aprotinin and 45,000 patients receiving aminocaproic acid showed increased risks of in-hospital death from aprotinin recipients with an excessive risk of death of 1.59 /100 patients.  (Schneeweiss, S)

In a study of over 4000 patients undergoing coronary artery bypass graft 59% increase in risk of in hospital death noted in patients receiving aprotonin compared to non-recipients, and there was a higher 5 year mortality rate was also present among aprotinin recipients (Mangano PT).

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