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Coagulation Factor — Haemostatic Agent Pregnancy: Safe in obstetric haemorrhage — human plasma-derived, pathogen-inactivated; indicated in PPH with fibrinogen <2 g/L

Fibrinogen Concentrate (Riastap)

Brand names: Riastap, FibCLOT

Adult dose

Dose: 30 mg/kg IV (typical surgical dose); target fibrinogen >1.5 g/L; in massive haemorrhage: 3–4 g IV as empiric dose (replace until fibrinogen >2 g/L)
Route: IV infusion (reconstituted in water for injection)
Frequency: Repeat guided by fibrinogen levels
Max: Guided by fibrinogen level target
Each vial = 1 g fibrinogen lyophilisate (requires reconstitution). Preferred over FFP for fibrinogen replacement — delivers defined dose, no volume overload, no risk of haemolytic reactions. Indicated when fibrinogen <1.5 g/L with surgical bleeding or <2 g/L in massive haemorrhage protocol.

Paediatric dose

Dose: 30 mg/kg
Route: IV
Frequency: As guided by fibrinogen level and bleeding
Max: Target fibrinogen >1.5 g/L
Neonates: fibrinogen concentrate is first-line for congenital afibrinogenaemia. Surgical paediatric haemorrhage: 30 mg/kg IV — BNFc and RCPCH guidelines.

Dose adjustments

Renal

No dose adjustment required — monitor fibrinogen levels.

Hepatic

Severe hepatic failure causes hypofibrinogenaemia — may require repeated dosing; target fibrinogen >1.5 g/L for invasive procedures.

Paediatric weight-based calculator

Neonates: fibrinogen concentrate is first-line for congenital afibrinogenaemia. Surgical paediatric haemorrhage: 30 mg/kg IV — BNFc and RCPCH guidelines.

Clinical pearls

  • FLOSEAL vs Riastap: FLOSEAL is a topical haemostatic matrix (thrombin + gelatin) applied locally to bleeding surgical sites; Riastap is systemic IV fibrinogen replacement — different mechanisms and indications; FLOSEAL is topical only
  • CRAYON study (2020): fibrinogen-first strategy in postpartum haemorrhage — early fibrinogen concentrate (2 g) did not reduce RBC transfusion vs placebo in mild PPH, but clinical benefit in massive haemorrhage protocol is established
  • Viscoelastic testing (ROTEM/TEG) guidance: FIBTEM/FF measures clot strength from fibrinogen — FIBTEM A10 <7 mm = give fibrinogen concentrate. ROTEM-guided protocols reduce blood product use in major surgery (cardiac, liver transplant, trauma)

Contraindications

  • Known hypersensitivity to human fibrinogen products
  • Fibrinogen levels already adequate (>2 g/L)

Side effects

  • Thromboembolic events (if excess dosing)
  • Anaphylaxis (rare — human plasma-derived)
  • Pyrexia
  • Allergic reactions

Interactions

  • Other coagulation factors (TXA used concurrently in massive haemorrhage protocols — synergistic)
  • Heparin (monitor anti-Xa — do not withhold heparin if indicated; fibrinogen supplementation is not pro-thrombotic at target-level dosing)

Monitoring

  • Fibrinogen level (Clauss method) before and 1 hour after infusion
  • Viscoelastic testing (ROTEM/TEG) if available
  • Signs of thromboembolic events
  • Coagulation screen (PT, APTT)

Reference: BNFc; BNF 90; NICE IPG guidance on massive haemorrhage; ESA Perioperative Haemostasis Guidelines 2022; WOMAN trial (Lancet 2017); MHRA SPC Riastap. Verify against your local formulary and the latest BNF before prescribing.

Related

Curated clinical cross-links plus same-class fallbacks.

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