Every minute
could
mean life
or death for
hemorrhaging
patients.1
In dire moments on the operating table, maintaining adequate fibrinogen levels is critical for patient outcomes, making early replacement key to effective care. Fibrinogen is the first clotting factor to critically deplete during a major bleed, resulting in acquired hypofibrinogenemia, also known as acquired fibrinogen deficiency (AFD).2-4
Patients can't afford to wait.In dire moments on the operating table, maintaining adequate fibrinogen levels is critical for patient outcomes, making early replacement key to effective care. Fibrinogen is the first clotting factor to critically deplete during a major bleed, resulting in acquired hypofibrinogenemia, also known as acquired fibrinogen deficiency (AFD).2-4
What is AFD?
Acquired fibrinogen deficiency (AFD), also called acquired hypofibrinogenemia, happens when fibrinogen levels drop due to consumption or hemodilution, such as in clinical situations that involve major blood loss. Fibrinogen (coagulation factor I) plays a key role in clotting, helping platelets stick together and forming the structural backbone that builds and stabilizes the fibrin clot.5-7
Consequences of
low fibrinogen
Low fibrinogen and the role of fibrinogen concentrate in major bleeding.
Current perioperative and obstetric guidance highlight low fibrinogen as an early marker to consider in major bleeding.8-13
Why is fibrinogen replenishment important?14,15
Fibrin is generated when thrombin cleaves fibrinogen, and it doesn’t just build the clot—it also traps thrombin. This sequestration protects thrombin from inhibition, allowing it to continue driving local hemostatic and procoagulant activity even after soluble thrombin has been inactivated.14,15
Fibrinogen thresholds
Fibrinogen thresholds by the numbers
Recognized thresholds highlight when fibrinogen replacement becomes critical.
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Why you need to act
Fibrinogen replacement has a narrow early window
Post-protamine levels can remain sub-hemostatic for up to 4 hours, creating a vulnerable gap after cardio pulmonary bypass.17
Here is how acquired fibrinogen deficiency (AFD) may have a drastic impact across several conditions3,18-20:
In cardiac surgery, low fibrinogen levels are linked to an increased risk of perioperative bleeding.19
Extremely high maternal, fetal, and neonatal mortality rates are linked with low fibrinogen levels.25
Severely injured patients who had low fibrinogen levels were ~5x more likely to die post-trauma.31
Hypofibrinogenemia was observed in 1/3 of patients undergoing cardiac surgery.20
Fibrinogen levels are highly correlated with bleeding severity during postpartum hemorrhage (PPH).26,27
For every 1g/L decrease in fibrinogen at trauma admission, 28-day mortality increases risk by 78%.2
Cardiopulmonary bypass-induced coagulopathy may result in AFD, and may increase mortality risk during cardiac surgery.21-24
AFD during PPH can result in impaired clot formation, prolonged bleeding, and maternal death.26,28-30
- 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
TRANSFUSION IS LIFE-SAVING—BUT NOT RISK-FREE
Life-saving transfusions come with trade-offs. Allogeneic blood products can trigger reactions (alloimmunization, febrile, allergic) and complications such as transfusion-related acute lung injury (TRALI), transfusion-associated circulatory overload (TACO), or sepsis.32
The Limitations of cryo
Cryo, developed in the 1960s to treat hemophilia A and von Willebrand disease (VWD), is the current standard of care for acquired fibrinogen deficiency in the U.S., although safety concerns have prompted some European countries to move from cryo to FC.16,33-35
Despite its widespread use, the very nature of how cryo is manufactured and stored can result in limitations with its use35:
On average, it can take 15 to 30 minutes for cryo to thaw, and additional time for its delivery to point of care.36,37
The extremely short shelf life after thawing leads to high cryo wastage rates.38
The concentration of fibrinogen (and other clotting factors) varies across cryo units, complicating
dosing accuracy.35
Adverse events associated with cryo: viral transmission, allergic reactions, TRALI, and volume overload.35,39
High rates of blood product waste occur in the OR
Cryo waste in the OR
The OR accounts for 63.2% of all cryoprecipitate waste.38
Product Expiration Leads
to Discard
59.4% of wasted blood products* are discarded because they expire before use.38
Improper Temperature Control
31.3% of wasted blood products* are unusable due to storage at an incorrect temperature.38
*Blood products include platelets, red blood cells, and fresh frozen plasma.38
Did you know?
In a 2018 study of 301 women with obstetric hemorrhage at seven hospitals (six in the U.S. and one in England), cryo was issued in 23% of patients and 17% of all cryoprecipitate units still ended up being wasted.40
Fibrinogen Concentrate
FC was first approved in Brazil in 1963 and in the European Union in 1966—and for more than 60 years, it’s remained a virally inactivated, precisely-dosed alternative.8,41
FC can offer advantages in the management of patients with uncontrolled bleeding for several reasons17,33,42:
Reconstitutes in
minutes
at room
temperature.19
Consistent amount of
fibrinogen simplifies
dosing
with treatment accuracy.43-45
Is stored
unfrozen.19
Viral inactivation
reduces risk of
transfusion-
transmitted infections.19,45
Shelf-life
of up to
several years.19
Adverse events associated
with FC may include6: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.
AROUND THE WORLD, GUIDELINES support FIBRINOGEN CONCENTRATE
Global guidelines recognize fibrinogen concentrate as an option for managing bleeding associated with low fibrinogen levels.8-10,33,46
U.S. Guidance
American Society of Anesthesiologists (ASA) guidelines say FC can be considered in AFD when replacing fibrinogen to support hemostasis.33
American College of Obstetricians and Gynecologists (ACOG) notes that FC may be preferred over cryoprecipitate to reduce the risk of viral pathogen transmission in postpartum hemorrhage.46
European Guidance
In patients undergoing cardiovascular surgery, European guidelines support treatment with fibrinogen concentrate if bleeding is accompanied by hypofibrinogenemia.10
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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