Every minute
could
mean life
or death for

hemorrhaging
patients.1

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In dire moments on the operating table, replenishing clotting factors like fibrinogen is
vital to patient survival. Clinical evidence has demonstrated that fibrinogen is the first
clotting factor to critically deplete during a major bleed, resulting in acquired fibrinogen
deficiency (AFD)—underscoring the importance of early fibrinogen replacement.2-4

Patients can't afford to wait.

In dire moments on the operating table, replenishing clotting factors like fibrinogen is vital to patient survival.

Clinical evidence has demonstrated that fibrinogen is the first clotting factor to critically deplete during a major bleed, resulting in acquired fibrinogen deficiency (AFD)—underscoring the importance
of early fibrinogen replacement.5

Consequences of
low fibrinogen

Fibrinogen loss during a major bleed can have significant adverse effects and may negatively impact patient recovery post‑surgery. Here is how acquired fibrinogen deficiency (AFD) may have a drastic impact across several conditions3,5-8:

  • In cardiac surgery, low fibrinogen levels are linked to an increased risk of perioperative bleeding.7
  • Extremely high maternal, fetal, and neonatal mortality rates are linked with low fibrinogen levels.13
  • Severely injured patients who had low fibrinogen levels were ~5x more likely to die post-trauma.19
  • Hypofibrinogenemia was observed in 1/3 of patients undergoing cardiac surgery.8
  • Fibrinogen levels are highly correlated with bleeding severity during postpartum hemorrhage (PPH).14,15
  • Every 1 g/L decrease in trauma admission fibrinogen increases 28-day mortality risk by 78%.2
  • Cardiopulmonary bypass-induced coagulopathy may result in AFD, and may increase mortality risk during cardiac surgery.9-12
  • AFD DURING postpartum hemorrhage (PPH) can result in impaired clot formation, prolonged bleeding, and maternal death.14,16-18
  • Fibrinogen levels ≤ 100 mg/dL ARE an independent risk factor for death in trauma patients undergoing massive transfusion.3
  • In cardiac surgery, low fibrinogen levels are linked to an increased risk of perioperative bleeding.7
  • Extremely high maternal, fetal, and neonatal mortality rates are linked with low fibrinogen levels.13
  • Severely injured patients who had low fibrinogen levels were ~5x more likely to die post-trauma.19
  • Hypofibrinogenemia was observed in 1/3 of patients undergoing cardiac surgery.8
  • Fibrinogen levels are highly correlated with bleeding severity during postpartum hemorrhage (PPH).14,15
  • Every 1 g/L decrease in trauma admission fibrinogen increases 28-day mortality risk by 78%.2
  • Cardiopulmonary bypass-induced coagulopathy may result in AFD, and may increase mortality risk during cardiac surgery.9-12
  • AFD DURING postpartum hemorrhage (PPH) can result in impaired clot formation, prolonged bleeding, and maternal death.14,16-18
  • Fibrinogen levels ≤ 100 mg/dL ARE an independent risk factor for death in trauma patients undergoing massive transfusion.3

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Limitations of current
standard of care

Cryoprecipitate (cryo), developed in the 1960s to treat hemophilia, is the current standard of care for acquired fibrinogen deficiency in the United States.20,21 Despite its widespread use, the very nature of how cryo is manufactured and stored can result in limitations with its use22:

  • On average, it can take 15 to 30 minutes for cryo to thaw, and additional time for its delivery to point of care.23,24

  • The extremely short shelf life leads to high cryo wastage rates.25

  • The concentration of fibrinogen (and other clotting factors) varies across cryo units, complicating
    dosing accuracy.22,26,27

  • Adverse events associated with cryo: viral transmission, allergic reactions, transfusion-related acute lung injury (TRALI), and volume overload.22,28

Clinical Guideline Recommendations

These are just some of the safety concerns which have led to European countries stopping the practice of administering cryo, turning to fibrinogen concentrate (FC) instead.22,29

Fibrinogen Concentrate

The American Society of Anesthesiologists Guidelines recommend fibrinogen concentrate as an option in patients with excessive bleeding.20

In situations where time is of the essence, early fibrinogen replacement with FC offers advantages in the management of patients with uncontrolled bleeding for several reasons5,20,30:

  • Reconstitutes in minutes
    at room temperature.7

  • Consistent amount of fibrinogen simplifies
    dosing with treatment accuracy.31-33

  • Is stored unfrozen.

  • Viral inactivation reduces risk of
    transfusion-transmitted infections.7,33

  • Shelf-life of up to
    several years.7

  • Adverse events associated
    with FC may include34:    Allergic or anaphylactic reactions.Thromboembolic complications, including pulmonary embolism, myocardial infarction, deep vein thrombosis, and arterial thrombosis.Generalized reactions, including chills,
    fever, nausea, and vomiting.

Fibrinogen Concentrate use across clinical conditions

The benefits and risks of FC for early fibrinogen replacement can be seen in both acquired fibrinogen deficiency (AFD) and congenital fibrinogen deficiency (CFD).

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Formulary Integration

This playbook is designed to guide you through the critical process of evaluating, proposing, and implementing fibrinogen concentrate within your institution.

We hope to equip you with the right materials to make a compelling case for the adoption of FC, thereby elevating the standard of care of massive transfusion protocols.

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