Trasylol® administration may cause fatal anaphylactic or anaphylactoid reactions. Fatal reactions have occurred with an initial (test) dose as well as with any of the components of the dose regimen. Fatal reactions have also occurred in situations where the initial (test) dose was tolerated. The risk for anaphylactic or anaphylactoid reactions is increased among patients with prior aprotinin exposure and a history of any prior aprotinin exposure must be sought prior to Trasylol® administration. The risk for a fatal reaction appears to be greater upon re-exposure within 12 months of the most recent prior aprotinin exposure. Trasylol® should be administered only in operative settings where cardiopulmonary bypass can be rapidly initiated. The benefit of Trasylol® to patients undergoing primary CABG surgery should be weighed against the risk of anaphylaxis associated with any subsequent exposure to aprotinin. (See CONTRAINDICATIONS, WARNINGS and PRECAUTIONS.)
Trasylol® (aprotinin injection), C284 H432 N84 O79 S7, is a natural proteinase inhibitor obtained from bovine lung.
Trasylol is indicated for prophylactic use to reduce perioperative blood loss and the need for blood transfusion in patients undergoing cardiopulmonary bypass in the course of coronary artery bypass graft surgery.
Published Studies Related to Trasylol (Aprotinin)
Comparative evaluation of the effects of tranexamic acid and low-dose aprotinin
on post-valvular heart surgery bleeding and allogenic transfusion. 
Bleeding diathesis and allogenic transfusion after complex heart surgery, such as
heart valve surgery, may result in complications such as transfusion reaction,
viral infection, postoperative infection, haemodynamic disturbance, prolonged
stay in the intensive care unit and hospital, renal and respiratory failure and
Impact of aprotinin and renal function on mortality: a retrospective single center analysis. [2011.08.30]
BACKGROUND: An estimated up to 7% of high-risk cardiac surgery patients return to the operating room for bleeding. Aprotinin was used extensively as an antifibrinolytic agent in cardiac surgery patients for over 15 years and it showed efficacy in reducing bleeding. Aprotinin was removed from the market by the U.S. Food and Drug Administration after a large prospective, randomized clinical trial documented an increased mortality risk associated with the drug. Further debate arose when a meta-analysis of 211 randomized controlled trials showed no risk of renal failure or death associated with aprotinin. However, only patients with normal kidney function have been studied... CONCLUSIONS: Lessons learned from our experience using aprotinin in the perioperative setting as an antifibrinolytic during open cardiac surgery should guide us in testing future antifibrinolytic drugs for not only efficacy of preventing bleeding, but for overall safety to the whole organism using long-term clinical outcome studies, including those with varying degree of baseline kidney function.
A Randomized Trial of Aprotinin-Free Fibrin Sealant Versus Absorbable Hemostat. [2011.08.25]
Background: This study evaluated the safety and hemostatic effectiveness of a tranexamic acid- and aprotinin-free fibrin sealant versus an absorbable hemostat in soft tissue during elective retroperitoneal or intra-abdominal surgery. Materials and Methods: This randomized, active-controlled, multicenter study enrolled patients who were undergoing elective retroperitoneal or intra-abdominal surgery and required adjunctive hemostatic measures at the target bleeding site (TBS)...
Aprotinin and classic wound drainage are unnecessary in total hip replacement - a prospective randomized trial. [2011.01.27]
BACKGROUND: Classic wound drainage is still common in hip replacement but its benefit is doubtful. The role of systemic administration of proteinase inhibitors like aprotinin to avoid perioperative blood loss is still unclear... CONCLUSION: The administration of aprotinin did not achieve the desired reduction of perioperative blood loss. Hence, costs and two severe allergic drug reactions in our study represent arguments against its use in regular treatment. Furthermore, it seems that wound drainage is neglectable in hip replacement and can be substituted by a sole compression treatment.
A randomized, placebo-controlled trial of aprotinin to reduce primary graft dysfunction following lung transplantation. [2011.01]
CONCLUSIONS: There was no statistically significant difference in the incidence of the primary endpoint between groups in the study. Excess renal failure related to aprotinin administration in a patient population at high risk for the event was not observed. (c) 2010 John Wiley & Sons A/S.
Clinical Trials Related to Trasylol (Aprotinin)
Phase I Study of Aprotinin in Advanced Breast Cancer [Terminated]
There is an intimate relationship between processes which promote growth, invasion, and
metastasis of cancers, and processes which regulate blood clotting. The enzymes uPA and
PAI-1 are key regulators of the remodeling of recently formed blood clots, and there is
substantial information linking greater levels of uPA and PAI-1 in breast cancers with a
greater likelihood of breast cancer recurrence and death. As uPA and PAI-1 are excellent
markers for a cancer's aggressive clinical behavior, uPA and PAI-1 may be potential targets
for anticancer therapy. Aprotinin is an inhibitor of uPA activation, and has been approved
by the FDA to reduce blood loss in patients undergoing cardiopulmonary bypass surgery.
Studies in animals and limited studies in patients have shown that Aprotinin slows the growth
of tumors. Our hypothesis is that uPA is chronically activated in malignancies, and that
inhibition of uPA by Aprotinin would slow the rate of progression of breast cancer.
Aprotinin US Special Access Protocol [Available]
This is a special access protocol that will allow physicians access to aprotinin during the
temporary marketing suspension. The program will provide aprotinin for treatment of surgical
patients undergoing coronary artery bypass graft (CABG) surgery requiring cardiopulmonary
bypass (CPB) who are at increased risk of bleeding and transfusion when, in the opinion of
the treating physician, the patients require it, there is no acceptable alternative therapy,
and when there is a clearly favorable benefit-risk for the drug in that individual patient.
Effects of Aprotinin During Cardiac Surgery/Long Term Death Rates [Active, not recruiting]
The dept. of Anesthesiology currently has a database of subjects whom had surgery and
received either Aprotinin or Amicar in the OR. The current viewpoint is that Aprotinin is
more harmful than Amicard. In an effort to see what the long term outcomes were for subjects
whom had surgery here at Upstate, it was decided to look at long term death rates to see if
any differences. A student t-test will be used to determine statistical significance where a
p value of <0. 05 will be deemed significant. Using data from 462 subjects that had undergone
cardiac surgery at SUNY Upstate Medical University, CABG only and the long term mortality
rate from the Mangano, et. al. publications, the unadjusted mortality for the two drugs are
Aprotinin 5. 4% and Amicar 1. 2%. A power analysis was performed using the hospital mortality
rates of 5. 4% and 1. 2% with the sample size in the propensity data and a p-value of 0. 05.
The result was a power of 81. 7%.
Effect of Aprotinin on Transfusion Requirements in Patients Undergoing Elective Spinal Fusion Surgery [Completed]
The objective of this study is to evaluate the safety and efficacy of aprotinin as compared
to placebo, in reducing the need for blood transfusion in adult subjects undergoing elective
spinal fusion surgery involving 3 to 7 vertebral levels with instrumentation
Effect of Aprotinin on Transfusion Requirements and Blood Loss in Patients Undergoing Elective Primary Total Hip Replacement [Completed]
The purpose of this study is to assess if aprotinin (BAY A0128), given intravenously during
surgery, is safe and can help reduce the amount of bleeding and the need for a blood
transfusion during hip replacement surgery. Patients undergoing major surgery are at risk
for significant blood loss. Because of this, there is a need for drugs that will help slow
the amount of bleeding during surgery.
Reports of Suspected Trasylol (Aprotinin) Side Effects
Renal Failure (451),
Unevaluable Event (402),
Renal Injury (381),
Emotional Distress (354),
Renal Impairment (351),
Stress (333), more >>
Page last updated: 2013-02-10