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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.)
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TRASYLOL SUMMARY
TRASYLOL®
(aprotinin injection)
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.
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NEWS HIGHLIGHTS
Published Studies Related to Trasylol (Aprotinin)
Tranexamic acid and aprotinin in low- and intermediate-risk cardiac surgery: a non-sponsored, double-blind, randomised, placebo-controlled trial. [2009.08]
OBJECTIVE: Tranexamic acid has been suggested to be as effective as aprotinin in reducing blood loss and transfusion requirements after cardiac surgery. Previous studies directly comparing both antifibrinolytics focus on high-risk cardiac surgery patients only or suffer from methodological problems. We wanted to compare the effectiveness of tranexamic acid versus aprotinin in reducing postoperative blood loss and transfusion requirements in the patient group representing the majority of cardiac surgery patients: low- and intermediate-risk patients... CONCLUSION: Aprotinin has clinically significant advantages over tranexamic acid in patients with normal renal function scheduled for low- or intermediate-risk cardiac surgery.
The effect of epsilon-aminocaproic acid and aprotinin on fibrinolysis and blood loss in patients undergoing primary, isolated coronary artery bypass surgery: a randomized, double-blind, placebo-controlled, noninferiority trial. [2009.07]
BACKGROUND: Until recently, aprotinin was the only antifibrinolytic drug with a licensed indication in cardiac surgery in the United States. The most popular alternative, epsilon-aminocaproic acid (EACA), has not been adequately compared with aprotinin. We undertook this study to test the hypothesis that EACA, when dosed appropriately, is not inferior to aprotinin at reducing fibrinolysis and blood loss... CONCLUSIONS: When dosed in a pharmacologically guided manner, EACA is not inferior to aprotinin in reducing fibrinolysis and blood loss in patients undergoing primary, isolated coronary artery bypass surgery.
A possible association between aprotinin and improved survival after radical surgery for mesothelioma. [2009.02.15]
BACKGROUND: Aprotinin has been used to decrease blood loss with complicated cardiac surgery but has not been investigated in extrapleural pneumonectomy, an operation that does not use cardiopulmonary bypass. In this prospective, randomized, placebo-controlled, double-blind trial, the authors investigated whether aprotinin decreased blood loss in patients who underwent this operation... CONCLUSIONS: Aprotinin decreased blood loss. After accounting for covariate effects, there was a significant comparative benefit with aprotinin in postoperative survival. This finding was unexpected and could not be considered conclusive because of the small size of the current study. A confirmatory study may be warranted. (c) 2009 American Cancer Society.
A possible association between aprotinin and improved survival after radical surgery for mesothelioma. [2009.01.06]
BACKGROUND:: Aprotinin has been used to decrease blood loss with complicated cardiac surgery but has not been investigated in extrapleural pneumonectomy, an operation that does not use cardiopulmonary bypass. In this prospective, randomized, placebo-controlled, double-blind trial, the authors investigated whether aprotinin decreased blood loss in patients who underwent this operation... CONCLUSIONS:: Aprotinin decreased blood loss. After accounting for covariate effects, there was a significant comparative benefit with aprotinin in postoperative survival. This finding was unexpected and could not be considered conclusive because of the small size of the current study. A confirmatory study may be warranted. Cancer 2009. (c) 2009 American Cancer Society.
Aprotinin for patients exposed to clopidogrel before off-pump coronary bypass. [2008.12]
To verify whether low-dose aprotinin reduces blood loss and blood product usage in patients with clopidogrel exposure within 5 days before off-pump coronary artery bypass, 51 patients with clopidogrel exposure were randomized in a double-blind fashion to receive low-dose aprotinin (25 patients), or placebo (26 patients)...
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.
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.
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.
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Page last updated: 2009-10-20
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