Trasylol (Aprotinin): Uses, Dosage & Side Effects
A serine protease inhibitor used to reduce blood loss and transfusion requirements during coronary artery bypass graft surgery with cardiopulmonary bypass
Trasylol (aprotinin) is a naturally occurring serine protease inhibitor classified as an antifibrinolytic agent. It is used exclusively in a hospital setting to reduce blood loss and the need for blood transfusions during coronary artery bypass graft (CABG) surgery performed with cardiopulmonary bypass (heart-lung machine). Trasylol works by inhibiting key enzymes in the coagulation and inflammatory cascades, including plasmin, kallikrein, and trypsin. Due to its specific safety profile, including a risk of anaphylaxis upon re-exposure and concerns about renal and cardiovascular outcomes, Trasylol is reserved for patients at high risk of significant perioperative blood loss and is prescribed only after careful benefit-risk assessment by a specialist cardiac surgeon or anesthesiologist.
Quick Facts: Trasylol
Key Takeaways
- Trasylol (aprotinin) is an antifibrinolytic drug used exclusively during coronary artery bypass graft surgery to reduce blood loss and minimize the need for blood transfusions in high-risk patients.
- Patients who have previously received aprotinin face a significantly increased risk of severe anaphylactic reactions upon re-exposure, especially within 12 months; an IgG antibody test is required before administration.
- Trasylol was temporarily withdrawn from global markets in 2007 over safety concerns but was re-approved in several countries after regulatory re-evaluation confirmed a favorable benefit-risk balance in its restricted indication.
- Common side effects include abnormal kidney function tests; uncommon but serious adverse events include myocardial infarction, stroke, acute kidney injury, and thrombotic events.
- Trasylol is administered only by qualified healthcare professionals in a hospital surgical setting, with emergency resuscitation equipment immediately available throughout the procedure.
What Is Trasylol and What Is It Used For?
Trasylol contains the active substance aprotinin, a naturally occurring polypeptide consisting of 58 amino acids with a molecular weight of approximately 6,512 daltons. Originally isolated from bovine lung tissue, aprotinin has been used in clinical practice since the 1960s, initially for the treatment of acute pancreatitis and later finding its most significant application in cardiac surgery. The drug is classified under the Anatomical Therapeutic Chemical (ATC) code B02AB01, placing it within the group of antihemorrhagics, specifically as a proteinase inhibitor.
Aprotinin functions as a broad-spectrum serine protease inhibitor. Its primary mechanism of action involves forming reversible, stoichiometric enzyme-inhibitor complexes with several key proteases. By inhibiting plasmin, the principal enzyme responsible for dissolving blood clots (fibrinolysis), aprotinin helps to stabilize clot formation at surgical sites, reducing post-operative bleeding. Simultaneously, by inhibiting kallikrein, aprotinin attenuates the contact activation system (intrinsic coagulation pathway) and reduces the generation of bradykinin, a potent vasodilator and mediator of inflammation. This dual action on both the fibrinolytic and inflammatory pathways makes aprotinin particularly effective in the context of cardiopulmonary bypass, where the exposure of blood to the artificial surfaces of the bypass circuit triggers a profound systemic inflammatory response.
During cardiopulmonary bypass (CPB) surgery, the patient's blood is diverted through an extracorporeal circuit (heart-lung machine) that oxygenates the blood and maintains circulation while the heart is stopped for surgical repair. This process subjects the blood to significant mechanical stress and contact with non-biological surfaces, activating the coagulation cascade, fibrinolytic system, complement system, and inflammatory mediators. The result is a complex hemostatic disturbance that can lead to excessive perioperative bleeding, often necessitating blood transfusions and sometimes requiring surgical re-exploration. Aprotinin addresses multiple elements of this pathological cascade, making it an effective agent for reducing blood loss in this specific clinical setting.
The approved indication for Trasylol is highly specific: it is used to reduce blood loss and the need for blood transfusions in adult patients undergoing isolated coronary artery bypass graft surgery with cardiopulmonary bypass who are at increased risk of major blood loss. Risk factors that may justify the use of aprotinin include:
- Re-do cardiac surgery: Patients undergoing repeat sternotomy, where adhesions from previous operations increase the risk of surgical bleeding.
- Complex or prolonged bypass procedures: Cases involving extended cardiopulmonary bypass times, where the hemostatic disturbance is more severe.
- Pre-existing coagulopathy: Patients with pre-existing bleeding disorders or those taking antiplatelet or anticoagulant medications that cannot be discontinued.
- Patient refusal of blood products: Situations where blood transfusion is not an option due to the patient's religious or personal beliefs.
- Anticipated high blood loss: Based on surgical assessment and patient-specific factors such as anemia, small body surface area, or multiple comorbidities.
It is important to understand that Trasylol is not a first-line antifibrinolytic agent for routine cardiac surgery. The decision to use aprotinin is made by the cardiac surgeon and anesthesiologist after a careful assessment of the individual patient's risks and benefits, taking into account the availability of alternative antifibrinolytic agents such as tranexamic acid and aminocaproic acid. Trasylol should only be prescribed by specialists experienced in coronary artery bypass surgery.
Trasylol has a notable regulatory history. It was voluntarily withdrawn from most global markets in November 2007 following preliminary results from the BART (Blood Conservation Using Antifibrinolytics in a Randomized Trial) study, which suggested increased mortality compared to lysine analogue alternatives. However, subsequent re-analysis of the BART data revealed significant methodological issues, and additional evidence led the European Medicines Agency (EMA) to re-approve aprotinin for restricted use in 2012. The current approved indication is narrower than the original, limited to isolated CABG surgery with CPB in high-risk patients. Aprotinin remains unavailable in the United States as of 2025.
What Should You Know Before Receiving Trasylol?
Contraindications
There are absolute contraindications that prevent the use of Trasylol. Understanding these is essential for patient safety, as the consequences of administering aprotinin when contraindicated can be life-threatening.
- Hypersensitivity: Do not use Trasylol if you have a known allergy (hypersensitivity) to aprotinin or any of the other ingredients in the product (sodium chloride, water for injection). Previous anaphylactic or anaphylactoid reactions to aprotinin are an absolute contraindication.
- Positive aprotinin-specific IgG antibody test: If a blood test shows the presence of aprotinin-specific IgG antibodies, it indicates an elevated risk of severe anaphylactic reaction. Trasylol must not be administered in this case.
- Previous aprotinin exposure without antibody testing: If you have been treated, or suspect you have been treated, with aprotinin or aprotinin-containing fibrin sealants within the preceding 12 months, and it is not possible to perform an aprotinin-specific IgG antibody test before surgery, Trasylol must not be used. This precaution exists because the risk of anaphylaxis is substantially higher upon re-exposure.
Warnings and Precautions
Aprotinin carries a risk of anaphylactic or anaphylactoid reactions, which can be fatal. While allergic reactions are uncommon in patients receiving aprotinin for the first time, the risk increases substantially with re-exposure, particularly within 12 months of a previous dose. A small test dose (1 ml) must be administered before the therapeutic dose, and standard emergency resuscitation equipment (including epinephrine/adrenaline) must be immediately available. Antihistamines (H1 and H2 blockers) may be given 15 minutes before the test dose as a precautionary measure.
Before receiving Trasylol, inform your medical team if any of the following apply to you:
- Kidney problems: If you have pre-existing renal impairment, Trasylol should only be used if the physician and surgeon consider the benefits to outweigh the risks. Aprotinin has been associated with renal adverse effects, including elevated serum creatinine and acute kidney injury. Your kidney function will be closely monitored during and after surgery.
- Previous aprotinin exposure: If you have been treated, or suspect you have been treated, with aprotinin or aprotinin-containing fibrin sealant at any time in the past, you must inform your medical team. Even exposure more than 12 months ago may still carry some increased risk of allergic reaction, and an IgG antibody test should be performed.
Trasylol will only be administered after your physician has performed appropriate blood tests to determine whether treatment is suitable. The aprotinin-specific IgG antibody test is the primary screening tool. If this test is positive, or if it cannot be performed in a patient with suspected prior exposure, alternative antifibrinolytic agents (such as tranexamic acid) should be used instead.
Throughout the administration of Trasylol, you will be carefully monitored for signs and symptoms of allergic reactions. These may include skin flushing, rash, hives, itching, breathing difficulty, wheezing, low blood pressure, rapid heartbeat, nausea, and abdominal discomfort. If any signs of an allergic reaction appear, the infusion will be stopped immediately and appropriate treatment will be administered.
It is standard practice to administer heparin (a blood-thinning medication) during cardiopulmonary bypass surgery. Aprotinin can affect certain laboratory tests used to monitor heparin anticoagulation, particularly the activated clotting time (ACT) as measured by celite-based methods. The kaolin-based ACT or protamine titration method should be used instead to ensure accurate monitoring. Your surgical team will use appropriate methods to determine the correct heparin dose.
Children and Adolescents
The safety and efficacy of Trasylol in patients under 18 years of age have not been established. There are no adequate clinical data to support the use of aprotinin in pediatric cardiac surgery. The decision to use aprotinin in a pediatric patient would require exceptional circumstances and must be based on a thorough benefit-risk assessment by the treating physician.
Pregnancy and Breastfeeding
If you are pregnant, breastfeeding, think you might be pregnant, or are planning to become pregnant, you should inform your medical team before receiving Trasylol. Animal studies have not shown evidence of teratogenicity or harmful effects on reproductive function. However, there are limited clinical data on the use of aprotinin during human pregnancy. As coronary artery bypass surgery during pregnancy is an extremely rare event, the clinical experience is minimal.
If you are pregnant or breastfeeding, Trasylol should only be used if the physician and surgeon consider that the potential benefits clearly outweigh the potential risks to the fetus or nursing infant. Your medical team will discuss the risks and benefits of using this medication with you in the context of your specific clinical situation.
How Does Trasylol Interact with Other Drugs?
As Trasylol is used exclusively in the controlled hospital environment of cardiac surgery, drug interactions are managed by the surgical and anesthesia team. However, several clinically significant interactions must be considered when planning the perioperative medication regimen.
Major Interactions
| Interacting Drug | Effect | Clinical Advice |
|---|---|---|
| Streptokinase | Aprotinin inhibits plasmin and thereby directly antagonizes the fibrinolytic action of streptokinase, rendering it ineffective | Do not co-administer. If thrombolysis is needed, aprotinin must be discontinued and an appropriate interval allowed before administering streptokinase. |
| Urokinase | Aprotinin inhibits plasmin and antagonizes the fibrinolytic effect of urokinase, significantly reducing its therapeutic efficacy | Avoid concurrent use. The combination renders thrombolytic therapy ineffective and should be avoided in clinical practice. |
| Alteplase (rt-PA) | Although alteplase acts primarily on plasminogen rather than directly through plasmin, aprotinin can still reduce the efficacy of alteplase-mediated fibrinolysis | Avoid concurrent use. If thrombolytic therapy is required, discontinue aprotinin and allow sufficient time for its effects to dissipate before initiating alteplase. |
| Aminoglycoside antibiotics | Aprotinin may enhance the nephrotoxic effects of aminoglycosides (such as gentamicin, tobramycin, amikacin) through additive renal injury mechanisms | Use with caution. Monitor renal function closely if aminoglycosides are required in the perioperative period. Consider alternative antibiotics where possible. |
| Heparin | Aprotinin does not directly interact with heparin but affects certain coagulation tests (celite-ACT) used to monitor heparin therapy, potentially leading to under-dosing of heparin | Use kaolin-based ACT or protamine titration methods rather than celite-based ACT for monitoring heparin dosing during CPB. Administer heparin according to weight-based protocols. |
Additional Considerations
Aprotinin's broad protease-inhibitory activity means it has the potential to interact with any medication that depends on serine protease activity for its mechanism of action. In the perioperative setting, the anesthesia team will carefully review all concomitant medications and adjust the treatment plan accordingly.
It is recommended that heparin be administered according to a weight-based protocol both before and after surgery, with anticoagulation monitored using a kaolin-based activated clotting time (ACT) method or a protamine titration assay. The celite-based ACT is prolonged by aprotinin and does not accurately reflect the degree of heparin anticoagulation, which could lead to inadequate heparin dosing and increase the risk of thrombotic complications.
Although not a true drug interaction, it is important to note that aprotinin is derived from bovine (cattle) lung tissue. Patients who have been exposed to bovine-derived products may have pre-existing antibodies that could contribute to hypersensitivity reactions. This is particularly relevant in the context of prior exposure to aprotinin-containing fibrin sealants or topical hemostats used in previous surgical procedures.
What Is the Correct Dosage of Trasylol?
Trasylol is a hospital-administered medication that is never self-administered. The dosing is determined and supervised by the cardiac surgical and anesthesia team. The medication is given intravenously (into a vein) through a central venous catheter while the patient is supine (lying down). Aprotinin should not be administered through the same intravenous line as other medications, particularly corticosteroids, which are known to be incompatible in solution.
Adults
The standard dosing protocol for adult patients undergoing CABG surgery is as follows:
Step 1: Test Dose
Before the therapeutic dose is administered, all patients must receive a test dose of 1 ml of Trasylol (10,000 KIE) to assess for potential hypersensitivity. This test dose is given at least 10 minutes before the loading dose. Antihistamine premedication (H1 and H2 receptor antagonists) may be given 15 minutes before the test dose at the discretion of the physician.
Step 2: Loading Dose
If no signs of allergy are observed after the test dose, a loading dose of 100–200 ml (1–2 million KIE) is administered as a slow intravenous infusion over 20–30 minutes. The infusion rate should not exceed 5–10 ml per minute to minimize the risk of hypotension and other infusion-related reactions.
Step 3: Continuous Infusion
Following the loading dose, a continuous maintenance infusion of 25–50 ml per hour (250,000–500,000 KIE/hour) is maintained for the duration of the surgical procedure, at a maximum rate of 5–10 ml per minute.
Step 4: Pump Prime Dose (Optional)
An additional dose of aprotinin may be added to the cardiopulmonary bypass pump prime solution at the discretion of the surgical team. The total dose of aprotinin from all sources should not exceed 700 ml (7 million KIE) per surgical procedure.
| Phase | Dose | Rate |
|---|---|---|
| Test dose | 1 ml (10,000 KIE) | Slow IV injection, 10 min before loading dose |
| Loading dose | 100–200 ml (1–2 million KIE) | Over 20–30 minutes (max 5–10 ml/min) |
| Maintenance infusion | 25–50 ml/hour (250,000–500,000 KIE/hr) | Continuous during surgery (max 5–10 ml/min) |
| Maximum total dose | 700 ml (7 million KIE) | Per surgical procedure |
Children
The safety and efficacy of Trasylol in children and adolescents under 18 years of age have not been established. There are no approved dose recommendations for the pediatric population. Any use in children would be off-label and must be based on an individual benefit-risk assessment by the treating physician.
Elderly Patients
There are no specific dose adjustments recommended for elderly patients. However, elderly patients are more likely to have pre-existing renal impairment and other comorbidities that may affect the benefit-risk balance of aprotinin use. Close monitoring of renal function is particularly important in this population.
Patients with Renal Impairment
There are no specific dose adjustments recommended for patients with renal impairment. However, aprotinin has been associated with renal adverse events, and pre-existing renal impairment may increase this risk. The decision to use Trasylol in patients with kidney problems should be based on a careful assessment of the potential benefits versus the risks, and renal function should be monitored closely during and after treatment.
Overdose
There is no specific antidote for aprotinin overdose. Because Trasylol is administered exclusively by medical professionals in a controlled surgical environment, overdose is rare. In the event of accidental overdosage, treatment is symptomatic and supportive. The medication has a relatively short terminal half-life of approximately 7 hours, and the effects will gradually resolve as the drug is metabolized and eliminated.
What Are the Side Effects of Trasylol?
Like all medicines, Trasylol can cause side effects, although not everybody gets them. The side effects listed below have been observed in clinical trials and post-marketing surveillance. Because Trasylol is used in the complex setting of cardiac surgery, it can sometimes be difficult to distinguish side effects of the drug from complications of the surgery itself or from the effects of cardiopulmonary bypass.
It is important to be aware that even though allergic reactions are uncommon in patients receiving aprotinin for the first time, patients who receive Trasylol more than once have a substantially increased risk of allergic or anaphylactic reactions. The symptoms of an allergic reaction may include difficulty breathing, decreased blood pressure, itching, rash, hives, and nausea. If any of these symptoms occur during administration, the infusion will be stopped immediately and appropriate treatment will be initiated by the medical team.
Common
- Abnormal kidney function tests (increased blood creatinine levels)
Uncommon
- Chest pain (myocardial ischemia, coronary artery occlusion/thrombosis)
- Heart attack (myocardial infarction)
- Pericardial effusion (fluid accumulation around the heart)
- Blood clots (thrombosis) in blood vessels
- Stroke (decreased or interrupted blood flow to the brain)
- Acute kidney injury (including renal tubular necrosis)
- Decreased urine output (oliguria)
- Severe allergic reaction (anaphylactic/anaphylactoid reaction)
Rare
- Arterial thrombosis (blood clots in arteries)
- Pulmonary embolism (blood clot in the lungs)
Very Rare
- Injection or infusion site reactions, including swelling and thrombophlebitis
- Disseminated intravascular coagulation (DIC) – a serious condition affecting blood clotting throughout the body
- Coagulopathy (inability of blood to clot normally)
- Anaphylactic shock – a life-threatening severe allergic reaction with circulatory collapse
Because Trasylol is administered in a hospital surgical setting, the medical team will be monitoring you continuously. However, if you experience any of the following symptoms during or after receiving Trasylol, alert the nearest healthcare professional immediately: sudden chest pain, difficulty breathing, swelling of the face or throat, skin rash or hives, dizziness or feeling faint, sudden weakness on one side of the body, sudden confusion, or severe reduction in urine output.
Renal Considerations
The renal safety of aprotinin has been a subject of considerable scientific investigation and debate. Several large observational studies and the BART trial raised concerns about an increased risk of renal dysfunction and the need for dialysis in patients receiving aprotinin compared to lysine analogue antifibrinolytics. Elevated serum creatinine levels are the most commonly observed adverse event, occurring in up to 10% of patients.
The mechanism of aprotinin-associated renal injury is believed to involve accumulation of the peptide in the proximal renal tubular cells, where it is taken up by receptor-mediated endocytosis and metabolized by lysosomal enzymes. At high concentrations, this accumulation may lead to tubular cell injury. Risk factors for aprotinin-associated renal adverse events include pre-existing renal impairment, prolonged cardiopulmonary bypass time, advanced age, diabetes mellitus, and concomitant use of other nephrotoxic agents.
Current evidence suggests that the renal risk is manageable with appropriate patient selection, adequate hydration, avoidance of concomitant nephrotoxins, and close perioperative monitoring of renal function. Patients should have their serum creatinine and urine output monitored closely for at least 48–72 hours after surgery.
Cardiovascular Considerations
The cardiovascular safety of aprotinin has also been the subject of extensive study. Observational studies, including the large Mangano et al. (2006) study published in the New England Journal of Medicine, suggested associations between aprotinin use and increased risks of myocardial infarction, stroke, and mortality. However, these findings were based on non-randomized data and subject to significant confounding by indication (sicker patients being more likely to receive aprotinin).
The EMA re-evaluation that led to the re-approval of aprotinin in 2012 concluded that when used in its restricted indication (isolated CABG with CPB in high-risk patients), the cardiovascular risks are acceptable given the benefits of reduced blood loss and transfusion requirements. Nonetheless, clinicians must carefully weigh the potential cardiovascular risks against the anticipated benefits on an individual patient basis.
How Should Trasylol Be Stored?
Trasylol is stored and handled by the hospital pharmacy and medical staff. Patients do not need to store this medication at home, as it is administered exclusively in a hospital setting during surgery. However, the following storage requirements apply:
- Temperature: Store at or below 25°C (77°F). Do not freeze.
- Light protection: Keep in the original packaging to protect from light. Aprotinin is sensitive to light and should not be exposed to direct sunlight or intense artificial light for prolonged periods.
- Expiry date: Do not use Trasylol after the expiry date stated on the carton after “EXP”. The expiry date refers to the last day of the stated month.
- Visual inspection: Before administration, the solution must be inspected for particulate matter and discoloration. The solution should be clear and colorless. Do not use if particles or discoloration are observed.
- Unused solution: Any remaining solution after use should not be stored for later use. Discard unused portions according to local regulations for pharmaceutical waste.
Trasylol is compatible with and can be diluted in glucose 20% solution, hydroxyethyl starch solution, and Ringer’s lactate solution. Chemical and physical stability of the diluted solution has been demonstrated for 6 hours at 25°C. From a microbiological standpoint, the diluted product should be used immediately unless preparation was performed under controlled and validated aseptic conditions.
Keep this medicine out of the sight and reach of children. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help to protect the environment.
What Does Trasylol Contain?
Active Substance
The active substance in Trasylol is aprotinin, present at a concentration of 10,000 kallikrein inhibitor units (KIE) per milliliter. Aprotinin is a naturally occurring polypeptide derived from bovine (cattle) lung tissue. It consists of 58 amino acid residues and has a molecular weight of approximately 6,512 daltons. The molecule contains three disulfide bonds that maintain its characteristic three-dimensional structure, which is essential for its protease-inhibitory activity.
The unit of measurement “KIE” (Kallikrein Inhibitor Einheit/Unit) refers to the kallikrein inhibitor unit, which quantifies the ability of aprotinin to inhibit kallikrein, one of its primary target enzymes. This unit system is specific to aprotinin and reflects its biological activity rather than its mass.
Inactive Ingredients (Excipients)
- Sodium chloride: Used as a tonicity agent to make the solution isotonic with body fluids, ensuring patient comfort and safety during intravenous administration.
- Water for injections: The solvent used to dissolve the active ingredient and excipients, prepared to pharmaceutical-grade standards to ensure sterility and absence of pyrogens.
Appearance and Packaging
Trasylol is presented as a clear, colorless solution for injection or infusion. It is supplied in 50 ml glass vials. The solution should be clear and free from visible particles before use. Each vial contains 500,000 KIE of aprotinin (50 ml at 10,000 KIE/ml).
Frequently Asked Questions About Trasylol
Trasylol (aprotinin) is an antifibrinolytic medication that reduces blood loss during coronary artery bypass graft (CABG) surgery performed with cardiopulmonary bypass. It works by inhibiting enzymes that break down blood clots and trigger inflammation. It is reserved for patients at high risk of major bleeding and is administered only in a hospital surgical setting by qualified healthcare professionals. The decision to use Trasylol is made after careful assessment of the individual patient's risk factors and the availability of alternative treatments.
Trasylol was voluntarily withdrawn from most global markets in November 2007 after preliminary results from the BART trial suggested higher mortality rates compared to alternative antifibrinolytic drugs (tranexamic acid and aminocaproic acid). However, subsequent re-analysis revealed significant methodological flaws in the BART study. In 2012, the European Medicines Agency (EMA) re-evaluated the evidence and concluded that the benefits of aprotinin outweigh the risks when used in its restricted indication: isolated CABG surgery with CPB in patients at high risk of major blood loss. The drug was re-approved with stricter prescribing requirements and enhanced monitoring.
Prior exposure to aprotinin significantly increases the risk of a severe allergic reaction (anaphylaxis). If you have received aprotinin before, or suspect you may have (including through aprotinin-containing fibrin sealants), you must inform your medical team. An aprotinin-specific IgG antibody blood test must be performed before re-administration. If the test is positive, Trasylol cannot be used. If the test cannot be performed, and you have received aprotinin within the last 12 months, Trasylol must not be given. Even with a negative antibody test, re-exposure carries some residual risk, and the medical team will take extra precautions.
The main alternatives to Trasylol for reducing blood loss during cardiac surgery are the synthetic lysine analogues: tranexamic acid (TXA) and epsilon-aminocaproic acid (EACA). Tranexamic acid is the most widely used antifibrinolytic in cardiac surgery worldwide and is generally considered to have a more favorable safety profile. Both drugs work by inhibiting the conversion of plasminogen to plasmin, thereby reducing fibrinolysis. The choice between aprotinin and lysine analogues depends on the individual patient's risk profile, previous drug exposure, and clinical circumstances.
Yes, Trasylol has been associated with renal adverse events. The most common is an increase in serum creatinine levels, which occurs in up to 10% of patients. More serious renal complications, including acute kidney injury and renal tubular necrosis, occur less frequently. Patients with pre-existing kidney problems, diabetes, advanced age, or prolonged bypass times are at higher risk. Your surgical team will monitor your kidney function closely during and after surgery. The benefits of reduced blood loss must be weighed against the potential renal risks in each individual patient.
As of 2025, aprotinin (Trasylol) is not available in the United States. While the EMA re-approved the drug for restricted use in Europe in 2012, the FDA has not reinstated approval in the US. In American cardiac surgical practice, tranexamic acid and aminocaproic acid are the standard antifibrinolytic agents used to reduce perioperative bleeding. Availability may vary in other countries; patients should consult their local healthcare system for current status.
References
This article is based on the following peer-reviewed sources, international guidelines, and regulatory documents:
- 1 European Medicines Agency (EMA). Aprotinin-containing medicinal products – CHMP assessment report on the benefit-risk balance. EMA/409136/2012. London: EMA; 2012.
- 2 Fergusson DA, Hébert PC, Mazer CD, et al. A comparison of aprotinin and lysine analogues in high-risk cardiac surgery. N Engl J Med. 2008;358(22):2319-2331. doi:10.1056/NEJMoa0802395
- 3 Mangano DT, Tudor IC, Dietzel C. The risk associated with aprotinin in cardiac surgery. N Engl J Med. 2006;354(4):353-365. doi:10.1056/NEJMoa051379
- 4 Royston D. The current place of aprotinin in the management of bleeding. Anaesthesia. 2015;70(Suppl 1):46-53. doi:10.1111/anae.12907
- 5 Society of Thoracic Surgeons Blood Conservation Guideline Task Force. 2021 STS/SCA/AmSECT Clinical Practice Guidelines on Patient Blood Management. Ann Thorac Surg. 2021;112(1):339-382.
- 6 Hutton B, Joseph L, Fergusson D, Mazer CD, Shapiro S, Bhatt DL. Risks of harms using antifibrinolytics in cardiac surgery: systematic review and network meta-analysis of randomised and observational studies. BMJ. 2012;345:e5798. doi:10.1136/bmj.e5798
- 7 Health Canada. Re-evaluation of the benefit-risk profile of aprotinin (Trasylol). Ottawa: Health Canada; 2011.
- 8 Dietrich W, Spannagl M, Jochum M, et al. Influence of high-dose aprotinin treatment on blood loss and coagulation patterns in patients undergoing myocardial revascularization. Anesthesiology. 1990;73(6):1119-1126.
- 9 European Association for Cardio-Thoracic Surgery (EACTS). Guidelines on Cardiopulmonary Bypass in Adult Cardiac Surgery. Eur J Cardiothorac Surg. 2020;57(2):210-251.
- 10 McMullan V, Alston RP. Aprotinin and cardiac surgery: a sorry tale of evidence misused. Br J Anaesth. 2013;110(5):675-678. doi:10.1093/bja/aet008
Editorial Team
This article has been written and reviewed by the iMedic medical editorial team according to our strict editorial standards. Our team consists of licensed physicians, pharmacists, and medical researchers with expertise in clinical pharmacology and cardiac surgery.
Content developed by iMedic's medical writing team based on current international guidelines (EMA, FDA, STS, EACTS) and peer-reviewed pharmacological and surgical research.
Independently reviewed and fact-checked by the iMedic Medical Review Board, comprising board-certified specialists in clinical pharmacology, cardiac anesthesiology, and cardiothoracic surgery.
All medical claims are supported by Level 1A evidence (systematic reviews, meta-analyses, and randomized controlled trials) following the GRADE evidence framework.
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