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Bedside Snapshot
  • Key Clotting Factor: Fibrinogen is substrate for fibrin clot formation; low levels impair hemostasis
  • Common in Hemorrhage: Hypofibrinogenemia common in massive hemorrhage, trauma, obstetric hemorrhage, liver failure, DIC
  • Target Levels: Typically target >150-200 mg/dL in active major bleeding; higher targets (>200-300 mg/dL) in obstetric hemorrhage or trauma-associated coagulopathy
  • Two Main Products: Fibrinogen concentrate (RiaSTAP) offers rapid, predictable dosing without blood typing; cryoprecipitate more widely available but variable content and transfusion risks
  • Massive Transfusion Protocols: Used as part of MTPs, often guided by labs (Clauss fibrinogen) or viscoelastic testing (TEG/ROTEM FIBTEM)
  • Clinical Pearl: Fibrinogen is often the first coagulation factor to fall critically low in major trauma and OB hemorrhage, so early replacement can improve clot firmness
Brand & Generic Names
  • Generic Name: Fibrinogen concentrate (human)
  • Brand Names: RiaSTAP (fibrinogen concentrate), and cryoprecipitate (pooled plasma product)
Medication Class

Human plasma-derived fibrinogen replacement; hemostatic agent; coagulation factor concentrate

Pharmacology

Mechanism of Action:

  • Fibrinogen (factor I) is a soluble plasma glycoprotein synthesized in the liver and circulating in blood
  • During hemostasis, thrombin cleaves fibrinogen into fibrin monomers, which polymerize and cross-link (via factor XIII) to form a stable fibrin clot
  • Adequate fibrinogen levels are essential for clot strength and stability; low fibrinogen impairs clot formation and firmness
  • Fibrinogen concentrate provides purified human fibrinogen; cryoprecipitate also provides von Willebrand factor, factor VIII, and factor XIII, which may be advantageous

Pharmacokinetics:

  • Onset: Rapid increase in plasma fibrinogen levels within minutes to hours after IV administration
  • Half-life: Approximately 3-4 days for fibrinogen; shorter in consumptive coagulopathy
  • Dosing: Fibrinogen concentrate dosed in grams (typically 3-4 g for adults); cryoprecipitate dosed in units (typically 10 units for adults, each containing ~200-250 mg fibrinogen)
Dosing & Administration

Available Forms:

  • Fibrinogen concentrate (RiaSTAP): Lyophilized vials with standardized 1 g amounts, reconstituted with sterile water and given IV
  • Cryoprecipitate: Frozen plasma product, each unit typically contains 200-250 mg fibrinogen, plus vWF, factor VIII, factor XIII; ABO-compatible transfusion preferred but not always required in emergency

Dosing for Hypofibrinogenemia and Bleeding (Adult):

Indication / Scenario Fibrinogen Concentrate (RiaSTAP) Cryoprecipitate Target Fibrinogen Level
Major trauma / surgery 3-4 g IV 10 units IV >150-200 mg/dL
Postpartum hemorrhage 2-4 g IV 10-15 units IV >200-300 mg/dL per OB MTP protocols
Congenital fibrinogen deficiency 50-100 mg/kg IV 1 unit per 5-10 kg Target hemostasis; individualized
DIC / liver failure with bleeding 2-4 g IV 10 units IV >100-150 mg/dL; ongoing consumption may require repeated dosing
Empiric in massive transfusion 3-4 g IV per protocol 10 units IV per MTP Combined with FFP and platelets as per protocol
Pediatric 30-60 mg/kg IV 1 unit per 5-10 kg Individualized; consult pediatrics/hematology
Concentrate vs Cryoprecipitate: Fibrinogen concentrate provides fast, standardized correction without volume and delays of cryoprecipitate; cryo more available but variable fibrinogen content.
Contraindications

Contraindications:

  • Hypersensitivity to fibrinogen or human plasma products
  • None absolute in life-threatening hemorrhage (benefits typically outweigh risks)

Major Precautions:

  • Thrombosis risk: fibrinogen replacement may increase risk of VTE or arterial thrombosis, particularly in patients with underlying thrombotic tendencies
  • Transmission of infectious agents: though rare with modern screening, any plasma-derived product carries theoretical risk
  • Anaphylaxis or allergic reactions rare but possible
Adverse Effects

Common:

  • Generally well-tolerated in acute bleeding settings
  • Infusion-related reactions (fever, chills) more common with cryoprecipitate

Serious:

  • Thrombotic events (VTE, MI, stroke) especially with overcorrection or underlying prothrombotic state
  • Anaphylaxis or severe allergic reactions (rare)
  • Transmission of infections (very rare with modern processing)
Monitoring

Laboratory Monitoring:

  • Fibrinogen level (Clauss assay) before and after replacement
  • Viscoelastic testing (TEG FIBTEM or ROTEM) for real-time assessment of clot firmness
  • Coagulation panel (PT/INR, aPTT), hemoglobin, platelet count as part of massive transfusion monitoring

Clinical Monitoring:

  • Cessation or control of bleeding
  • Signs of thrombosis (chest pain, limb swelling, neurological changes)
  • Transfusion reactions (fever, chills, hypotension)
Indications / Clinical Uses (ICU/Hemorrhage Focus)
  • Trauma-associated coagulopathy: Major trauma with hypofibrinogenemia and active bleeding
  • Massive hemorrhage: Any massive transfusion setting where fibrinogen levels fall below target
  • Postpartum hemorrhage: Obstetric hemorrhage with hypofibrinogenemia (targets often higher, >200-300 mg/dL)
  • Congenital fibrinogen deficiency: Afibrinogenemia or severe hypofibrinogenemia with bleeding or surgery
  • DIC or liver failure with bleeding: Consumptive or synthetic hypofibrinogenemia with active hemorrhage
Clinical Pearls
First Factor to Fall: Fibrinogen is often the first coagulation factor to fall critically low in major trauma and OB hemorrhage, so early replacement can improve clot firmness.
Concentrate Advantages: Fibrinogen concentrate provides fast, standardized correction without volume and delays of cryoprecipitate; useful in massive transfusion protocols.
Viscoelastic Testing: Viscoelastic tests (low FIBTEM amplitudes on TEG/ROTEM) can identify fibrinogen deficiency even before lab fibrinogen results return, allowing earlier intervention.
MTP Integration: Work with hematology and transfusion medicine to build fibrinogen targets into massive transfusion protocols for your institution.
References
  • 1. Lexicomp. (2024). Fibrinogen concentrate (human): Drug information. Wolters Kluwer.
  • 2. Spahn, D. R., Bouillon, B., Cerny, V., et al. (2019). The European guideline on management of major bleeding and coagulopathy following trauma: Fifth edition. Critical Care, 23(1), 98. https://doi.org/10.1186/s13054-019-2347-3