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Antifibrinolytic — Cardiac Surgery Pregnancy: Section 4.6: 'There are no adequate and well-controlled studies in pregnant women. Animal studies did not provide any evidence of teratogenic or other embryotoxic effects of aprotinin. Aprotinin should be used throughout pregnancy only if the potential benefit justifies the potential risk.' Breastfeeding: unknown whether excreted in human milk; since aprotinin is not bioavailable after oral administration, any drug in the milk is not expected to have a systemic effect on the breast-fed child. Fertility: no adequate and well-controlled studies.

Aprotinin

Brand names: Trasylol

Aprotinin is an antifibrinolytic serine protease inhibitor used to reduce blood loss and transfusion requirements in selected patients undergoing cardiac surgery with cardiopulmonary bypass.

Adult dose

Dose: Adults only - prophylactic use to reduce blood loss and blood transfusion in patients at high risk of major blood loss undergoing ISOLATED coronary artery bypass graft (CABG) surgery (not CABG combined with other cardiovascular surgery). (1) Test dose: 1 ml (10,000 KIU), given to all patients at least 10 minutes before the remainder of the dose. (2) After an uneventful test dose, loading dose of 1-2 million KIU as a slow intravenous injection or infusion over 20-30 minutes after induction of anaesthesia and before sternotomy. (3) A further 1-2 million KIU added to the pump prime of the heart-lung machine. (4) Then a continuous infusion of 250,000-500,000 KIU per hour until the end of the operation.
Route: Intravenous (central venous catheter; patient supine; slowly, maximum 5-10 ml/min as injection or short infusion)
Frequency: Single treatment course around the operation: test dose, loading dose, pump-prime addition, then continuous infusion until the end of the operation
Max: In general, the total amount of aprotinin administered per treatment course should not exceed 7 million KIU
Strength: Aprotinin 10 000 KIU/ml Injection BP; each 50 ml vial contains 500,000 KIU (SPC section 2). SCOPE: the only licensed use (section 4.1) is prophylaxis in adult patients at high risk of major blood loss undergoing isolated CABG surgery, to be used only after careful consideration of benefits and risks and of available alternative treatments; the SPC states it should not be used when CABG is combined with another cardiovascular surgery because the benefit-risk balance in other cardiovascular procedures has not been established (section 4.4). No dose is written here for other cardiac or non-cardiac surgery. Consider an aprotinin-specific IgG antibody test before administration if available (section 4.2). Owing to the risk of allergic/anaphylactic reactions a H1 antagonist and a H2 antagonist may be given 15 minutes before the test dose, and standard emergency treatment for anaphylaxis must be readily available. To avoid physical incompatibility, aprotinin and heparin must each be added to the pump prime during recirculation to ensure adequate dilution before admixture with the other. The same central line lumen should not be used for any other medicinal product. Maintain adequate heparin anticoagulation (aprotinin is not heparin-sparing).

Dose adjustments

Renal

SPC section 4.2: available clinical experience suggests that patients with decreased renal function do not require special dose adjustment. Section 4.4: renal dysfunction could be triggered by aprotinin, particularly in pre-existing renal dysfunction, so careful consideration of risks and benefits is advised in patients with pre-existing impaired renal function or risk factors such as concomitant aminoglycosides.

Hepatic

SPC section 4.2: no data are available on dosage recommendations for patients with hepatic dysfunction.

Dose independently re-sourced from UK Summary of Product Characteristics (SPC) via MHRA Products — clinician-reviewed. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Hypersensitivity to the active substance or any of the excipients (section 4.3)
  • Positive aprotinin-specific IgG antibody test - increased risk of anaphylactic reaction (section 4.3)
  • If no IgG antibody test is possible: suspected previous exposure to aprotinin, including in fibrin sealant products during the last 12 months (section 4.3)

Side effects

  • About 11% of aprotinin-treated patients experienced adverse reactions; the most serious was myocardial infarction (section 4.8)
  • Allergic and anaphylactic/anaphylactoid reactions, including anaphylactic shock which may be life threatening; rare in patients with no prior exposure, but on re-exposure the incidence may reach the five percent level (5.0% for re-exposure within 6 months and 0.9% for re-exposure after more than 6 months) (section 4.8)
  • Myocardial ischaemia, coronary occlusion/thrombosis, myocardial infarction, pericardial effusion (section 4.8)
  • Thrombosis, embolic stroke, arterial thrombosis, pulmonary embolism; disseminated intravascular coagulation and coagulopathy (section 4.8)
  • Renal: oliguria, acute kidney injury, renal tubular necrosis, increased blood creatinine (section 4.8)
  • Injection and infusion site reactions, infusion site (thrombo-)phlebitis (section 4.8)

Interactions

  • Thrombolytic agents (streptokinase, urokinase, alteplase) - aprotinin has a dose-dependent inhibitory effect on their action; special attention to coagulation (section 4.5)
  • Potent nephrotoxic drugs (aminoglycosides, renin-angiotensin-aldosterone system inhibitors) - risk factor for renal dysfunction; special attention to kidney protection (section 4.5)
  • Heparin - physically incompatible when mixed undiluted; add separately to the pump prime during recirculation (section 4.2)

Monitoring

  • Anticoagulation during cardiopulmonary bypass: APTT and PTT should not be used (they become immeasurable); use individualised heparin management (computer-based dosing, anti-Xa or blood heparin measurements plus ACT) or regular ACT tests per institutional protocol (section 4.4)
  • Minimal celite ACT of 750 seconds or kaolin ACT of 480 seconds is recommended to maintain anticoagulation (section 4.4)
  • Renal function in patients with pre-existing renal dysfunction or risk factors (section 4.4)
  • Test dose observed for allergic/anaphylactic reaction at least 10 minutes before the remainder of the dose, with emergency treatment available (section 4.2)

Clinical monograph

How it works

It inhibits plasmin and other serine proteases, stabilising clot formation and reducing fibrinolysis.

Prescribing in practice

  • Anaphylactic and anaphylactoid reactions can occur, particularly on re-exposure, so a test dose and resuscitation facilities are required and prior exposure should be checked.
  • Use is restricted to defined cardiac surgical indications under specialist guidance following its earlier safety-driven suspension.
  • It is administered intravenously by experienced anaesthetic or surgical teams only.

Monitoring

Monitor for hypersensitivity reactions, renal function and coagulation parameters during and after administration.

Counselling the patient

  • The anaesthetic and surgical team should document any previous exposure to aprotinin.
  • Staff should observe closely for allergic reactions, especially at the start of administration.
  • Renal function should be reviewed after surgery.

Evidence & guidelines

Aprotinin was reintroduced for cardiac surgery following European regulatory re-evaluation of the BART trial and related data.

Reference: Trasylol SPC; BART Trial (2007); MHRA Safety Advice; ESA Perioperative Haemostasis Guidelines 2022; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.

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